# Ultherapy in Seoul > Ultherapy (microfocused ultrasound with visualization, MFU-V) in Seoul: how the treatment works, who it may suit, how a quote is built and what recovery involves, with the studies behind each answer. ## Ultherapy in Seoul Source: https://ultherapy-seoul.com/ Updated: 2026-10-24 Ultherapy® is the brand name for microfocused ultrasound with visualization (MFU-V), a non-surgical skin-lifting technology delivering focused acoustic energy at 1.5 mm, 3.0 mm and 4.5 mm depths. Its US regulatory pathway began with De Novo classification for non-invasive brow lift in 2009, followed by 510(k) clearances for additional indications. The visible result builds over 8–12 weeks. Published studies document improvement through their defined follow-up periods, often 180 days, while a small pilot followed some participants to one year; they do not establish one duration for every patient. Most people return to usual activity the same day, but temporary redness, swelling, tenderness, bruising, numbness or altered sensation can occur. Figure: MFU-V focal depths: 1.5, 3.0 and 4.5 mm MFU-V focal depths: 1.5, 3.0 and 4.5 mm. Tissue depth varies by location; not to anatomical scale. Figure: Street scene in Cheongdam-dong, Seoul ### What Ultherapy is, at a glance Ultherapy® is a brand of microfocused ultrasound with visualization (MFU-V). The device delivers focused ultrasound energy into three pre-set depths under the skin (typically 1.5 mm, 3.0 mm, and 4.5 mm) to create small zones of thermal coagulation in the dermis and the superficial musculoaponeurotic system (SMAS). Over the following weeks and months, fibroblasts in the treated planes respond with new collagen formation, which is the source of the gradual lift and tightening that patients see. A few things are worth fixing in mind before going further. Ultherapy is non-surgical, so it does not replace a facelift for advanced laxity. The visible result builds over two to three months. Fabi and Goldman assessed outcomes through 180 days; a separate 20-person pilot followed participants for one year, with 14 evaluable by blinded assessment. Neither study establishes a typical long-term duration or a fixed retreatment interval. And the device shows the clinician a live ultrasound image of the tissue being treated, the feature that sets it apart from generic HIFU platforms and has kept it in dermatology practices for over a decade[1,2]. The technology entered its US regulatory pathway through De Novo classification in 2009 for non-invasive brow lift, followed by 510(k) clearance for submental and lateral neck laxity in 2012 and for upper-chest (décolletage) wrinkle improvement in 2014. These are milestones in US FDA history, not proof of permitted uses outside the US or a complete list of current US indications. The [FDA's May 2026 device record](https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260618.pdf) documents a later US clearance. A treating clinician should confirm what applies locally and whether the procedure suits the individual patient. ### Clinician credentials Medical content on this site is reviewed by a Korean Board-Certified Dermatologist. [About the medical reviewer](https://ultherapy-seoul.com/about-the-clinician/) explains what that specialist qualification means. ### How to choose an Ultherapy clinic in Seoul When comparing Ultherapy clinics in Seoul, check who will treat you, which device and treatment plan they propose, what the quote includes, and how to reach the clinic afterward. Use the consultation to work through these five questions. 1. **[Clinician credentials](https://ultherapy-seoul.com/about-the-clinician/):** Who will assess you and perform the procedure? Ask how to verify their medical license, specialty qualifications and relevant training. 2. **[Device and treatment plan](https://ultherapy-seoul.com/what-is-ultherapy/):** Ask for the manufacturer and exact model, how the device and transducers are verified as genuine, and an explanation of the planned areas, line count, depths and use of real-time imaging. 3. **[Individual suitability](https://ultherapy-seoul.com/candidates-and-contraindications/):** Discuss your medical history, medicines and previous procedures. Ask about the expected benefit, risks and alternatives for your goals before agreeing to treatment. 4. **[Price inclusions](https://ultherapy-seoul.com/pricing-seoul/):** Request a written quote showing the treatment areas and line plan, pain management and follow-up, including any separate charges. 5. **[Aftercare contact](https://ultherapy-seoul.com/aftercare-downtime/):** Ask for written aftercare instructions and a contact for concerns after treatment, including after you return home. Confirm how and in which language you can communicate. ### The Seoul context Figure: Central Seoul streetscape near dermatology clinics in Gangnam Gangnam, Seoul: a commercial district where patients can compare dermatology clinics and travel logistics. Patients considering Ultherapy in Seoul can verify the device used, the treating clinician's credentials, and the proposed line and depth plan with each clinic. Korean dermatology researchers have published consensus protocols tailored to Asian facial anatomy: for example a multi-clinic consensus describing MFU-V line counts and depth sequencing for Korean male patients[3]. That paper supports the existence of a published protocol; it does not establish Seoul's device density or any individual clinician's treatment volume. [Delight Dermatology Clinic](https://hifuseoul.com/procedures/ultherapy-seoul/) lists its Ultherapy treatment and consultation details. The harder-to-verify reason is the assumption that prices are lower in Seoul. They sometimes are, but the gap has narrowed in recent years and the difference is not always meaningful once travel, accommodation, and a realistic margin for follow-up are accounted for. The pricing page on this site offers ranges rather than fixed numbers; the exact quote is finalised at consultation when the dermatologist has decided how many lines to deliver across which zones. ### The patient journey, end to end Consultation, optional preliminary photo review, treatment and follow-up are separate stages. Final assessment takes place in person. Figure: Patient journey from research to result review Consultation and treatment in Seoul; pre-visit photo review is optional. ### What a consultation looks like A consultation is typically thirty to forty-five minutes. The dermatologist reviews medical history, current medications (notably any anticoagulants), prior cosmetic treatments in the lower face and neck, and your aesthetic goals. The face and neck are then examined under good light, with attention to skin thickness, laxity grade, bony support, and any zones where MFU-V is contraindicated: for example, areas of permanent filler, recent surgical incisions, or active infection. If the dermatologist judges that MFU-V is appropriate, the recommended line count and zone mapping is shared together with a price quote. If a different modality (RF microneedling, thread lift, or, in advanced laxity cases, surgical consultation) would be a better match for your goals, that is discussed instead. ### References 1. Vachiramon V, Pavicic T, Casabona G, et al. Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. *J Cosmet Dermatol.* 2024;24(2):e16658. [doi:10.1111/jocd.16658](https://doi.org/10.1111/jocd.16658) · [PMID:39501429](https://pubmed.ncbi.nlm.nih.gov/39501429/) 2. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. *Clin Cosmet Investig Dermatol.* 2015;8:47-52. [doi:10.2147/CCID.S69118](https://doi.org/10.2147/CCID.S69118) · [PMID:25709486](https://pubmed.ncbi.nlm.nih.gov/25709486/) 3. Park JY, Hong W, Lee KC, et al. Customizing Microfocused Ultrasound With Visualization Treatment for Facial Lifting in Asian Men: Experience and Practical Insights From Korea. *J Cosmet Dermatol.* 2025;24(6):e70278. [doi:10.1111/jocd.70278](https://doi.org/10.1111/jocd.70278) · [PMID:40488260](https://pubmed.ncbi.nlm.nih.gov/40488260/) ## About the Medical Reviewer Source: https://ultherapy-seoul.com/about-the-clinician/ Updated: 2026-10-24 Ultherapy® (MFU-V) is a physician-operated device whose US FDA pathway began with De Novo classification in 2009, followed by 510(k) clearances in 2012 and 2014 for specific facial and chest indications. The clinician reviewing this site’s medical content is a Korean Board-Certified Dermatologist. ### Credentials Korean Board-Certified Dermatology specialist board, Ministry of Health and Welfare - **Korean Board-Certified Dermatologist.** In Korea, the Ministry of Health and Welfare confers this specialist title in dermatology. Because a physician operates MFU-V, it is the first qualification to ask about when comparing who would plan and deliver a session. ### Treatment expectations MFU-V results develop over months and are not permanent. Related reading: [candidates and contraindications](https://ultherapy-seoul.com/candidates-and-contraindications/) · [treatment FAQ](https://ultherapy-seoul.com/faq/) · [Ultherapy vs thread lift](https://ultherapy-seoul.com/ultherapy-vs-thread-lift/) · [Ultherapy for men](https://ultherapy-seoul.com/ultherapy-for-men/) · [the jawline and neck](https://ultherapy-seoul.com/ultherapy-jawline-and-neck/) · [whether it is worth it](https://ultherapy-seoul.com/is-ultherapy-worth-it/) ## Ultherapy Downtime and Recovery: What to Discuss Source: https://ultherapy-seoul.com/aftercare-downtime/ Updated: 2026-10-18 Returning to usual activities and recovering from treatment effects are different considerations after Ultherapy (MFU-V). Redness, swelling, tenderness, bruising or altered sensation can occur even when daily activities are possible. Plan aftercare and follow-up with the treating clinician. Figure: Gold dotted curves converge on a glowing point between wavy ivory layers on a navy background. ### Possible temporary effects The US instructions for use describe these effects after face and neck treatment. Their duration varies by symptom and person. [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) | Effect | Recovery discussion | | --- | --- | | Redness or swelling | May be visible after treatment | | Tenderness or bruising | Can persist after usual activities resume | | Numbness, tingling or muscle weakness | Discuss new or worsening symptoms promptly with the treating clinician | ### Questions about aftercare | Topic | What to ask | | --- | --- | | Work, exercise and travel | Which activities should I adjust for my treatment area and symptoms? | | Skincare and other procedures | When should I resume my products, makeup or other treatments? | | Medicines and follow-up | Which medicines need review, whom should I contact, and when is follow-up? | Ask for instructions suited to your treatment. Do not stop prescribed medicines on your own. ### Assessing results separately from recovery A retrospective MFU-V study assessed facial and neck outcomes at 90 and 180 days. Those observation points do not establish when every patient will see a result. Arrange a result review separately from any assessment of recovery symptoms.[2] [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/) [Ultherapy in summer](https://ultherapy-seoul.com/ultherapy-in-summer/) ### Frequently asked questions ### Does returning to activities mean no recovery effects? No. Being able to work or go out can coexist with redness, swelling, tenderness, bruising or altered sensation. ### What should I ask my treating clinician about aftercare? Ask about activity changes, skincare, medicines, symptoms that need assessment and the follow-up plan. For an example of a clinic's written instructions, see [Delight Dermatology's ultrasound-lifting aftercare sheet](https://hifuseoul.com/aftercare/ultrasound-lifting/en/). ### When to contact the clinic Seek prompt clinical assessment for new facial weakness, movement asymmetry, significant or worsening numbness, spreading redness, worsening swelling, blistering or skin breakdown. Sudden facial droop, limb weakness or speech difficulty needs emergency assessment. Mild stable numbness can last several weeks, but should be discussed with the treating clinician. ### Risks and contraindications Redness, swelling, tenderness, bruising and altered sensation can occur. Postmarketing reports also include muscle weakness, burns, nodules and fat or volume loss; their frequency is uncertain. Discuss prior fillers and implants before treatment. In a 52-patient open-label trial across Fitzpatrick III–VI skin, the three reported adverse events resolved by day 90 without sequelae[1]. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. The full set of candidacy criteria is laid out on the [candidates and contraindications](https://ultherapy-seoul.com/candidates-and-contraindications/) page. ### References 1. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/) 2. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) ## Ultherapy Candidates and Contraindications Source: https://ultherapy-seoul.com/candidates-and-contraindications/ Updated: 2026-10-18 Ultherapy® (MFU-V) may suit mild-to-moderate facial laxity, good baseline skin quality and realistic expectations. Severe laxity may need surgical assessment. Existing keloids in the treatment area and a history of abnormal scarring require different precautions. Candidacy depends on examination, medical history and the device labeling, not age alone. Minimal or no laxity Skin still taut. No visible folds. Surface texture smooth. Little laxity to treat; discuss skincare. Mild to moderate Fine surface lines visible. Early small folds at rest. MFU-V may be suitable after examination. Moderate–severe Distinct wrinkle pattern. Moderate folds. Texture less even. Individual assessment; consider alternatives. Severe Deep wrinkles and folds. Marked surface laxity and crepe-like texture. Surgical consultation (SMAS lift) recommended. Skin laxity grades. Suitability depends on examination, not age alone. Ultherapy works well for a defined band of patients. For others it is less suited, and sometimes outright contraindicated. The published consensus is that MFU-V is most suited for patients with mild-to- moderate skin and soft tissue laxity; patients with severe laxity and marked platysmal banding are usually better served by surgical consultation[1]. ### Good candidates The clearest indication for MFU-V is mild to moderate laxity in patients who still have reasonable skin quality and bony support. Patients may have noticed: - A softening of the jawline contour with early jowl formation, but no significant submandibular skin redundancy. - Mild laxity of the neck (typically across the lateral neck and upper submental triangle) without prominent platysmal banding. - Brow descent producing a tired or heavy upper-lid appearance, again in the mild to moderate range. - Etched horizontal lines on the décolletage from sun exposure and sleeping position. Realistic expectations are part of the candidacy assessment. A good candidate understands that MFU-V is a tightening and modest lifting treatment, that the visible change emerges over two to three months, and that published follow-up does not establish one duration for everyone. Patients expecting a surgical-grade lift from a non-surgical session are poor candidates, not because of their anatomy but because they are setting themselves up for disappointment. The [aftercare and downtime page](https://ultherapy-seoul.com/aftercare-downtime/) sets out that recovery timeline week by week. ### Less-suited candidates Patients with advanced laxity, significant skin redundancy, or pronounced platysmal banding are usually better served by surgical consultation. MFU-V can still offer a modest improvement in these cases, but the gap between what the patient sees in the mirror and what the patient hoped for after treatment is large. A dermatologist will sometimes recommend a combination plan: for example, [MFU-V plus a thread lift](https://ultherapy-seoul.com/ultherapy-vs-thread-lift/), or MFU-V as a maintenance treatment after surgery: but will not suggest MFU-V alone as a substitute for a procedure the patient really needs. Patients with very thin, atrophic, or sun-damaged skin without meaningful underlying laxity also tend not to benefit. The collagen remodeling response that drives MFU-V results depends on a healthy dermal fibroblast population. The mechanism behind it is explained in [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/), and severely photodamaged skin may need a different first step, such as a structured topical and resurfacing protocol, before MFU-V is a useful next move. ### Candidacy at a glance | Criterion | Good fit | Less suited | | --- | --- | --- | | **Age range** | Age considered with anatomy | Age alone does not determine eligibility | | **Skin laxity** | Mild to moderate | Severe laxity or marked platysmal banding | | **Skin quality** | Reasonable baseline quality with a healthy dermal fibroblast population | Very thin, atrophic, or severely photodamaged skin | | **Expectations** | Tightening and modest lift; change over 2–3 months; duration reassessed individually | Expecting a surgical-grade lift from a non-surgical session | | **Prior treatments** | Temporary fillers or botulinum toxin | Permanent fillers or threads in the focal path; active infection | Realistic expectations are part of the candidacy assessment[1]. ### Contraindications and precautions These are the conditions that should stop or modify a planned treatment: | Category | Condition | Action | | --- | --- | --- | | **Not evaluated** | Pregnancy or breastfeeding | Treatment deferred | | **Absolute** | Open wounds or lesions; severe or cystic acne in the treatment area | Postponed until the area is clear | | **Precaution** | Recent surgery in the treatment area | Defer until the treating clinician confirms healing | | **Absolute** | Active or metallic implants in the treatment area | Do not treat the affected area under the US labeling | | **Relative** | Keloid or hypertrophic scarring history | Assess scarring history; avoid treatment directly over an existing keloid | | **Relative** | Active systemic autoimmune disease affecting skin | Specialist involvement before treatment | | **Not evaluated** | Anticoagulant use | Case-by-case decision with the prescribing physician | Prior fillers and threads require review of their type, location and timing. Active or metallic implants in the treatment area are contraindications under the US labeling; zone planning does not override that restriction. ### Combination treatments: what the evidence supports Many patients ask whether MFU-V can be sequenced with other dermatology treatments. Published safety data is reassuring. A retrospective review of 101 subjects who received MFU-V combined with botulinum toxin and/or temporary or semi-permanent dermal fillers within six months reported a 7% adverse event rate (bruising, swelling, paresthesia, one herpes simplex reactivation): consistent with the individual safety profiles of each treatment[2]. A separate study of suspension threads combined with MFU-V found preserved structural integrity of poly-L-lactic acid, polyethylene and polyamide threads, and greater neocollagenesis at three months when threads were combined with MFU-V compared to MFU-V alone[3]. [Delight Dermatology's Ultherapy FAQ](https://hifuseoul.com/procedures/ultherapy-seoul/#procedure-faq) covers common questions about choosing between treatments. MFU-V + botulinum toxin and/or dermal fillers (101 subjects) 7% adverse-event rate (bruising, swelling, paresthesia): consistent with the individual safety profiles of each treatment[2]. MFU-V + suspension threads Thread integrity preserved, with greater neocollagenesis at three months than MFU-V alone[3]. Safety of combination treatments with MFU-V ### What the consultation actually checks Figure: Gold dots and rings align vertically through overlapping ivory and blue waves on a navy background. A proper consultation is not a sales conversation. The dermatologist will examine the face and neck under good light, palpate the submental and jawline tissue to assess laxity grade and skin thickness, ask about prior cosmetic treatments (including those the patient may have forgotten: threads from years ago, permanent fillers from another country), review medications, and consider the patient's photographs at rest and with animation. If a different modality is a better fit, that is what will be recommended. Patients travelling from outside Korea may request an appointment without photographs. An optional photo and medication review can provide preliminary planning guidance, but it cannot confirm candidacy; the dermatologist makes the final decision after an in-person examination. To request a consultation you can [book directly through Delight Dermatology Clinic](https://hifuseoul.com/reserve/?utm_source=ultherapy-seoul.com&utm_medium=referral&utm_campaign=ultherapy-consultation&utm_content=booking-link&procedure=ultherapy-seoul) using the main reservation page; international consultation requests go through the same channel. Common patient questions are answered in the [treatment FAQ](https://ultherapy-seoul.com/faq/). ### Risks and contraindications Redness, swelling, tenderness, bruising and altered sensation can occur. Postmarketing reports also include muscle weakness, burns, nodules and fat or volume loss; their frequency is uncertain. Discuss prior fillers and implants before treatment. In a 52-patient open-label trial across Fitzpatrick III–VI skin, the three reported adverse events resolved by day 90 without sequelae[4]. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. ### References 1. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. *Clin Cosmet Investig Dermatol.* 2015;8:47-52. [doi:10.2147/CCID.S69118](https://doi.org/10.2147/CCID.S69118) · [PMID:25709486](https://pubmed.ncbi.nlm.nih.gov/25709486/) 2. Fabi SG, Goldman MP, Mills DC, et al. Combining Microfocused Ultrasound With Botulinum Toxin and Temporary and Semi-Permanent Dermal Fillers: Safety and Current Use. *Dermatol Surg.* 2016;42 Suppl 2:S168-76. [doi:10.1097/DSS.0000000000000751](https://doi.org/10.1097/DSS.0000000000000751) · [PMID:27128245](https://pubmed.ncbi.nlm.nih.gov/27128245/) 3. Casabona G. Safety of Combining Facial Lifting With Suspension Threads and Microfocused Ultrasound With Visualization. *J Drugs Dermatol.* 2020;19(4):367-370. [doi:10.36849/JDD.2020.4771](https://doi.org/10.36849/JDD.2020.4771) · [PMID:32272512](https://pubmed.ncbi.nlm.nih.gov/32272512/) 4. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/) ## Does Ultherapy Hurt? Pain Scores Reported in Studies Source: https://ultherapy-seoul.com/does-ultherapy-hurt/ Updated: 2026-10-24 The Ulthera System instructions for use describe momentary discomfort while the energy is being delivered, and a 2025 meta-analysis that pooled 0–10 pain scores from 785 patients found a mean of 4.85, which its authors called moderate pain[1]. In a split-neck trial, scores were higher after the deeper 4.5 mm pass than after the 3.0 mm pass[2]. The pain relief most reported in these studies was numbing cream and painkiller tablets. Figure: Range chart of how long discomfort typically lasts after Ultherapy, on a time scale from 1 hour to 6 weeks: momentary discomfort during treatment, discomfort after the procedure from 2 hours to 2 days, tenderness to the touch from 2 days to 2 weeks, and transient pain, paresthesia or tingling from 2 to 6 weeks ### What the treatment feels like Ultherapy delivers focused ultrasound one line at a time. Each line places a row of small heated points, called thermal coagulation points, at the depth of the transducer in use; the [Ulthera System instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) give the example of a 25 mm line at the standard 1.5 mm spacing, which holds 17 points. The same document lists pain among the effects reported in its clinical evaluation of the brow, under-chin and neck treatments: momentary discomfort while energy is being deposited, and discomfort after the procedure that "typically resolves within 2 hours and 2 days." Tenderness to the touch can follow and typically resolves within 2 days to 2 weeks. Among nerve effects, the instructions list transient pain, paresthesia (altered sensation) or tingling, which typically resolves in 2 to 6 weeks. Recovery in general is covered under [aftercare and downtime](https://ultherapy-seoul.com/aftercare-downtime/). ### Pain scores reported in studies The figures below are mean scores on 0–10 scales, where 0 is no pain. Figure: Chart of mean pain scores on a 0 to 10 scale: 4.85 in a meta-analysis of 785 patients, 4.62 for the face and neck, 5.58 for other body areas, and 4.50 in a 30-patient Ultherapy Prime case series on the jawline and neck Means with 95% confidence intervals, as each study reported them. - **Meta-analysis, 2025.** Of 42 studies of microfocused ultrasound with visualization (MFU-V), the technology behind Ultherapy, 18 contributed to a pooled pain estimate covering 785 patients: a mean of 4.85 (95% confidence interval 4.35–5.35). Patients treated on the face and neck had a mean of 4.62 (536 patients) and those treated on other body areas 5.58 (249 patients)[1]. - **Ultherapy Prime case series, 2025.** Thirty patients in an Asia-Pacific case series were treated for jawline and neck laxity after numbing cream applied for at least 30 minutes, with tablets added when needed. Scored straight after treatment, pain averaged 4.50 (95% confidence interval 3.75–5.18); the median was 4.00 and individual scores ran from 1 to 10[3]. - **Single-clinic questionnaire, 2025.** At one clinic in Bangkok, 231 patients rated pain at a mean of 2.75 after Ultherapy Prime on a paper questionnaire completed during their visit[4]. The studies differ in the areas treated, the number of lines, the pain relief given and when pain was scored. Merz North America funded the meta-analysis, and Merz Aesthetics sponsored the program behind the Prime case series. What changed with Prime is covered in [Ultherapy Prime vs Ultherapy](https://ultherapy-seoul.com/ultherapy-prime-vs-ultherapy/). ### Which depths and areas scored higher In a randomized split-neck trial, 24 participants had 45 lines with the 4.5 mm transducer and then 45 lines with the 3.0 mm transducer on each side of the neck. Each side was prepared for 30 minutes beforehand, one with a 2.5% lidocaine and 2.5% prilocaine cream alone and the other with the cream plus a capsaicin gel. On the cream-alone side, mean pain was 6.91 after the 4.5 mm pass, 5.69 after the 3.0 mm pass and 6.13 for the whole session[2]. Figure: Bar chart from a 24-person split-neck trial: with numbing cream alone, mean pain was 6.91 after the 4.5 mm pass, 5.69 after the 3.0 mm pass and 6.13 for the session; with cream plus capsaicin gel, 5.19, 4.18 and 4.94 Mean scores from one randomized split-neck trial of 24 participants. The transducers listed in the instructions for use treat at depths of 1.5, 3.0 or 4.5 mm, and the ultrasound image shows tissue to 8 mm below the skin. A 2026 narrative review of facial anatomy describes how unevenly the layers are supplied with nerves: the skin, the SMAS (superficial musculoaponeurotic system) and the periosteum covering bone are densely innervated, while subcutaneous fat contains few pain-sensing fibers[5]. Figure: Diagram in two parts: the three focal depths, 1.5, 3.0 and 4.5 mm, below a transducer on gel on a ruler to 8 mm; below that, facial layers from top to bottom: skin, SMAS and the periosteum over bone are densely innervated, subcutaneous fat has few pain-sensing fibers Depths from the instructions for use and nerve density from a 2026 review. ### Pain relief used in the studies - **Numbing cream.** The Prime case series applied a topical anesthetic for at least 30 minutes[3]; the neck trial used 10 grams of lidocaine and prilocaine cream under a covering dressing for 30 minutes[2]. - **Tablets.** In the case series, physicians added oral painkillers when needed, at a participant's request or as their routine practice[3]. Across the meta-analysis, oral medications such as ibuprofen and paracetamol, and topical creams, were the most reported forms of pain relief[1]. - **An experimental gel.** In the neck trial, adding 0.025% capsaicin gel to the cream lowered mean scores to 5.19, 4.18 and 4.94. Every participant felt burning and stinging on that side, which faded within 10 minutes of removal, and redness there lasted 112.67 minutes on average against 10.38 minutes on the cream-only side[2]. ### Questions to ask before your session 1. Which numbing cream will you use, and how long will it stay on before treatment starts? 2. Will you offer painkiller tablets, and when should I take them? 3. Which areas and depths are planned, and how many lines at each depth? 4. Can the energy level be changed for a sensitive area, and can we pause between lines? 5. Whom do I contact if numbness, tingling or soreness lasts beyond the first weeks? For the short-lived effects one Seoul clinic lists after a session, see [Delight Dermatology Clinic's answers on Ultherapy recovery](https://hifuseoul.com/procedures/ultherapy-seoul/#procedure-faq). Risks beyond pain, including fat loss, are covered in [Ultherapy fat loss and other reported risks](https://ultherapy-seoul.com/ultherapy-fat-loss/). ### Common questions ### How painful is Ultherapy on a scale of 0 to 10? A 2025 meta-analysis pooled pain scores from 785 patients in 18 studies and found a mean of 4.85, which its authors called moderate. Patients treated on the face and neck had a mean of 4.62. Oral medications such as ibuprofen and paracetamol, and topical creams, were the most reported forms of pain relief in those studies. ### How long does pain last after Ultherapy? The Ulthera System instructions for use say discomfort after the procedure typically resolves within 2 hours and 2 days, and tenderness to the touch within 2 days to 2 weeks. Transient pain, paresthesia or tingling, listed among the nerve effects, typically resolves in 2 to 6 weeks. ### Device document 1. Ulthera, Inc. [Ulthera System Instructions for Use, featuring DeepSEE technology for Ultherapy PRIME](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf), document 1016413IFU Rev00, 2026: sections 2.5.1 and 7.3.4 and table 3.4. ### References 1. Amiri M, Ajasllari G, Llane A, et al. Microfocused Ultrasound With Visualization (MFU-V) Effectiveness and Safety: A Systematic Review and Meta-Analysis. *Aesthet Surg J.* 2025;45(3):NP86-NP94. [doi:10.1093/asj/sjae228](https://doi.org/10.1093/asj/sjae228) · [PMID:39540440](https://pubmed.ncbi.nlm.nih.gov/39540440/) 2. Vachiramon V, Tanratana P, Anuntrangsee T, et al. The role of topical capsaicin gel in pain management during microfocused ultrasound treatment for neck laxity. *Skin Res Technol.* 2023;29(1):e13240. [doi:10.1111/srt.13240](https://doi.org/10.1111/srt.13240) · [PMID:36382669](https://pubmed.ncbi.nlm.nih.gov/36382669/) 3. Lim J, Siew TW, Xu Y. Early Experience With Ultherapy Prime in Asia Pacific: A Pilot Case Series. *Plast Reconstr Surg Glob Open.* 2025;13(11):e7269. [doi:10.1097/GOX.0000000000007269](https://doi.org/10.1097/GOX.0000000000007269) · [PMID:41282450](https://pubmed.ncbi.nlm.nih.gov/41282450/) 4. Panithaporn D. Pain, Erythema, and Edema After Facial Lifting With Ultherapy Prime or Ultherapy Legacy-A Survey Study. *J Cosmet Dermatol.* 2025;24(9):e70467. [doi:10.1111/jocd.70467](https://doi.org/10.1111/jocd.70467) · [PMID:40965929](https://pubmed.ncbi.nlm.nih.gov/40965929/) 5. Faria GEL, Chaves TP. Demystifying Pain During Microfocused Ultrasound: A Narrative Analysis of Facial Layer Sensitivity and Its Possible Correlation with Treatment Efficacy. *Aesthetic Plast Surg.* 2026;50(11):4359-4363. [doi:10.1007/s00266-026-05730-5](https://doi.org/10.1007/s00266-026-05730-5) · [PMID:41803309](https://pubmed.ncbi.nlm.nih.gov/41803309/) ## Ultherapy FAQ: Common Questions Answered Source: https://ultherapy-seoul.com/faq/ Updated: 2026-10-20 Published Ultherapy® (MFU-V) studies document improvement through their defined follow-up periods, often 180 days; some small studies report selected measures to 9–12 months, but they do not establish a universal duration. A session commonly takes 60–90 minutes and changes develop over the following months. Most people resume usual activity the same day, but temporary redness, swelling, tenderness, bruising, numbness or altered sensation can occur. Mean pain score was 4.5/10 with combined topical and oral analgesia in the Lim 2025 Asia-Pacific Ultherapy Prime case series (n=30); Harris 2015 reported safety outcomes across Fitzpatrick III–VI skin (n=52). Related topics: [how Ultherapy works](https://ultherapy-seoul.com/what-is-ultherapy/), [candidacy](https://ultherapy-seoul.com/candidates-and-contraindications/), [recovery](https://ultherapy-seoul.com/aftercare-downtime/) and [pricing](https://ultherapy-seoul.com/pricing-seoul/). Figure: Published Ultherapy follow-up windows: day 90, day 180, and a small one-year pilot Fabi and Goldman: 180-day follow-up. A separate one-year pilot enrolled 20 participants, with 14 evaluable by blinded assessment (PMID 27047630). ### How long does Ultherapy actually last? Published studies document improvement through their defined follow-up periods, often 180 days; some small studies report selected measures to 9–12 months, but they do not establish a universal duration. Retrospective data found 67% of subjects showed blinded-reviewer improvement and 77.7% physician-rated improvement at 180 days after a single MFU-V session, with no association between outcome and age or Fitzpatrick skin type. Ultherapy is not permanent. Maintenance timing is separate from efficacy duration and should be decided only after an individual reassessment.[1] *Source: Fabi SG, Goldman MP. (2014).* ### Is the treatment painful? Honestly: yes, it is uncomfortable, particularly at the deeper 4.5 mm depth over bony zones like the jawline. Most clinics use a combination of topical anesthetic cream, oral analgesia, and sometimes a short course of an anxiolytic to manage this. Pain tolerance varies more than most people expect; in a Singapore Asia-Pacific case series of 30 patients receiving an updated Ultherapy Prime protocol, mean pain score was 4.50 out of 10 with treatment described as well tolerated. The consultation will discuss the anesthesia plan that fits you. Discomfort can occur during and after treatment.[3] *Source: Lim J, Siew TW, Xu Y. (2025).* ### How many sessions will I need? For most patients, one well-mapped session is used before the result is reassessed. A second session is not an automatic continuation of the first: maintenance timing is separate from efficacy duration and is decided after an individual examination. Patients who want a stronger initial change are sometimes better served by a combination plan (for example, MFU-V plus a thread lift or RF microneedling) rather than repeated MFU-V sessions in quick succession. ### When will I see the result? A small day-of effect, mild tightening from the immediate thermal contraction, is visible to some patients. The real result builds slowly as new collagen forms. Changes develop over the following months; arrange result assessment with the clinician. Photographs in consistent lighting are the most reliable way to track it. ### Can Ultherapy be combined with thread lifts or filler? Yes, and combinations are common. Thread lifts can be performed before MFU-V or some weeks after, depending on the plan. Dermal filler placed recently changes the focal-path planning for MFU-V, so the order matters; the dermatologist will sequence treatments based on what you have had and what you want next. Patients who want broader dermal collagen stimulation alongside MFU-V's deeper SMAS work sometimes layer in other energy-based modalities: that decision is made in person at consultation. ### Are there side effects I should know about? Common, transient effects include redness, mild swelling for one to three days, and occasional bruising at the jawline. In a 52-patient open-label trial in Fitzpatrick III–VI skin, three reported adverse events (raised mild edema in two patients, moderately severe prolonged erythema with mild scabbing in one) all resolved by day 90 without sequelae. Reported adverse events include temporary numbness in a specific facial zone, transient weakness in a facial muscle, and small areas of skin sensitivity that resolve over weeks. Postmarketing reports also include nodules and fat or volume loss; their frequency is uncertain.[2] *Source: Harris MO, Sundaram HA. (2015).* ### Is Ultherapy safe for darker Asian skin? Published MFU-V studies include Fitzpatrick III–VI skin, and focused ultrasound does not target melanin in the way a surface pigment laser does. That evidence supports use across a broad range of skin tones, but it does not make treatment risk-free: temporary redness, swelling, tenderness, bruising or altered sensation can occur, and an in-person assessment is still required.[2,4,3] *Source: Harris MO, Sundaram HA. (2015); Park JY, Hong W, Lee KC, et al. (2025); Lim J, Siew TW, Xu Y. (2025).* ### How does this compare with surgical lifting? It does not, and a clinician who tells you it does is overselling. MFU-V is a non-surgical tightening and modest-lift treatment for patients with mild to moderate laxity. A surgical lift addresses skin redundancy and deeper tissue repositioning at a level no non-surgical device can match. The right framing is that MFU-V is one tool in the lifting category: well-suited for the right candidate, but not a replacement for surgery when surgery is what the patient actually needs. ### I am travelling to Seoul. What is the logistics timeline? International patients can discuss allowing three to five days in Seoul around treatment with the treating clinician. Day one is for consultation and treatment; day two allows rest; the remaining days allow any post-treatment check the dermatologist requests and some flexibility if swelling persists. A consensus from seven Korean dermatology clinics describes MFU-V line counts and depth sequencing for Korean male facial anatomy. A general appointment request does not require photographs. An optional photo and medication review can help with preliminary travel planning, but it cannot confirm candidacy; final diagnosis and treatment decisions follow an in-person examination.[4] *Source: Park JY, Hong W, Lee KC, et al. (2025).* ### What has been studied for neck and décolletage treatment? A study of 19 women used two HIFU sessions and six low-fluence Q-switched Nd:YAG laser sessions. Neck sagging and chest wrinkle scores improved, with 84% satisfaction at week 16. These HIFU findings do not establish outcomes for an MFU-V combination.[5] *Source: Nam JH, Choi YJ, Lim JY, Min JH, Kim WS. (2017).* ### What if I am on a medication or have a medical condition? Disclose everything at consultation, including non-prescription supplements. Anticoagulants, recent or planned cosmetic surgery, autoimmune skin conditions, prior fillers (especially permanent fillers), keloid history, pregnancy or breastfeeding, and active facial infections all change the plan or postpone it. The treating clinician assesses suitability based on medical history and an in-person examination. ### Which payment methods should international patients confirm? Korean dermatology clinics commonly accept payment in KRW by card or cash. Some accept advance deposits. Confirm accepted payment methods, the deposit policy, and total tax-inclusive fees with the treating clinic before booking. ### How do I book? [Delight Dermatology Clinic](https://hifuseoul.com/reserve/?utm_source=ultherapy-seoul.com&utm_medium=referral&utm_campaign=ultherapy-consultation&utm_content=booking-link&procedure=ultherapy-seoul) accepts consultation requests without a photograph. Photo review is optional and provides preliminary guidance only; final candidacy is decided after an in-person examination. ### Booking link [Book a consultation at Delight Dermatology](https://hifuseoul.com/reserve/?utm_source=ultherapy-seoul.com&utm_medium=referral&utm_campaign=ultherapy-consultation&utm_content=booking-link&procedure=ultherapy-seoul). Procedure details: [treatment steps, timeline and the published range](https://hifuseoul.com/procedures/ultherapy-seoul/). ### References 1. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) 2. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/) 3. Lim J, Siew TW, Xu Y. Early Experience With Ultherapy Prime in Asia Pacific: A Pilot Case Series. *Plast Reconstr Surg Glob Open.* 2025;13(11):e7269. [doi:10.1097/GOX.0000000000007269](https://doi.org/10.1097/GOX.0000000000007269) · [PMID:41282450](https://pubmed.ncbi.nlm.nih.gov/41282450/) 4. Park JY, Hong W, Lee KC, et al. Customizing Microfocused Ultrasound With Visualization Treatment for Facial Lifting in Asian Men: Experience and Practical Insights From Korea. *J Cosmet Dermatol.* 2025;24(6):e70278. [doi:10.1111/jocd.70278](https://doi.org/10.1111/jocd.70278) · [PMID:40488260](https://pubmed.ncbi.nlm.nih.gov/40488260/) 5. Nam JH, Choi YJ, Lim JY, Min JH, Kim WS. Synergistic effect of high-intensity focused ultrasound and low-fluence Q-switched Nd:YAG laser in the treatment of the aging neck and décolletage. *Lasers Med Sci.* 2017;32(1):109-116. [doi:10.1007/s10103-016-2092-7](https://doi.org/10.1007/s10103-016-2092-7) · [PMID:27766442](https://pubmed.ncbi.nlm.nih.gov/27766442/) ## Is Ultherapy Worth It? An Honest, Evidence-Based Look Source: https://ultherapy-seoul.com/is-ultherapy-worth-it/ Updated: 2026-10-18 For the right candidate, Ultherapy® (MFU-V) may be worth considering: a meta-analysis found about 77% of patients improved at 90 days and about 78% were satisfied, with an average pain score around 3/10. Most people resume usual activity the same day, but temporary redness, swelling, tenderness, bruising, numbness or altered sensation can occur. The trade-offs are straightforward: the result is gradual and modest rather than surgical, and published studies do not establish one duration for every patient. It is unlikely to fit someone expecting a facelift result, with severe laxity, or wanting a permanent change. Figure: Gold dots and rings align vertically through overlapping ivory and blue waves on a navy background. "Is it worth it" is really two questions: does it work, and does it work for you. The evidence answers the first reasonably well; the second is decided at a consultation. ### What the outcome data says A systematic review and meta-analysis of MFU for facial rejuvenation pooled 13 studies and 477 participants. It found an overall improvement response of about 77% at 90 days and 69% at 180 days on the Global Aesthetic Improvement Scale, with roughly 78% of patients satisfied or very satisfied at 90 days and 71% at 180 days, and an average pain score of about 3.1 out of 10 with no cases of intolerable pain[1]. A separate retrospective evaluation documented improvement at 180 days[3]. Some small studies report selected measures to 9–12 months, but these follow-up windows do not establish a universal duration. The durability caveat matters for value. A narrative review of face and neck laxity treatment found around half of patients rated much or very much improved at days 30 and 90, with the effect largely returning to baseline by day 360[2]. And a broader efficacy review noted that most controlled studies to date enrolled female patients, so individual results are better discussed case by case[4]. ### Where the value is: and where it isn't | Factor | Worth it if… | Reconsider if… | | --- | --- | --- | | **Laxity** | Mild to moderate | Severe laxity or heavy redundant skin | | **Expectations** | Gradual tightening and a modest lift | You want a surgical-grade or permanent change | | **Timeline** | You can wait 2–3 months for the result | You need a visible change immediately | | **Maintenance** | You accept reassessment before any maintenance session | You want one-and-done permanence | | **Downtime / pain** | You can accept possible short-lived redness, swelling or tenderness; ~3/10 average pain in the cited analysis is acceptable | You cannot tolerate treatment discomfort or subsequent tenderness | The PRIME pilot study reported a mean pain score of 4.5/10[7]. ### Value versus the alternatives Worth-it is also relative. The candidacy consensus places MFU-V firmly in the mild-to-moderate band: outside it, the spend rarely pays off[6]. Among non-surgical alternatives, a thread lift gives an immediate mechanical lift but the published evidence for its durability is limited[5], which is part of why some patients combine the two; that comparison is laid out in [Ultherapy vs thread lift](https://ultherapy-seoul.com/ultherapy-vs-thread-lift/). Cost is the other half of the equation: Ultherapy pricing factors are on the [pricing](https://ultherapy-seoul.com/pricing-seoul/) page, and whether you are a good candidate at all is covered in [candidates and contraindications](https://ultherapy-seoul.com/candidates-and-contraindications/). If you are weighing Ultherapy against other HIFU treatments, [a side-by-side review of the published evidence](https://hifuseoul.com/guides/hifu-vs-ultherapy-evidence/) compares outcomes, risks and costs. ### Risks and contraindications Ultherapy® (MFU-V) is well tolerated when performed by a trained dermatologist, but it is not risk-free. Common transient effects include redness and warmth (resolves in hours), mild swelling at 1–3 days, and occasional bruising at the jawline. Reported adverse events include temporary numbness in a specific facial zone, transient weakness of a facial muscle, and small areas of skin sensitivity. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. ### References 1. Ling J, Zhao H. A Systematic Review and Meta-Analysis of the Clinical Efficacy and Patients' Satisfaction of Micro-focused Ultrasound (MFU) Treatment for Facial Rejuvenation and Tightening. *Aesthetic Plast Surg.* 2023;47(5):1806-1823. [doi:10.1007/s00266-023-03384-1](https://doi.org/10.1007/s00266-023-03384-1) · [PMID:37198297](https://pubmed.ncbi.nlm.nih.gov/37198297/) 2. Al-Omair A, Bukhari A. Patient satisfaction of microfocused ultrasound treatments on the face and neck laxity: A narrative review. *J Cosmet Dermatol.* 2023;22(10):2671-2676. [doi:10.1111/jocd.15766](https://doi.org/10.1111/jocd.15766) · [PMID:37128835](https://pubmed.ncbi.nlm.nih.gov/37128835/) 3. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) 4. Contini M, Hollander MHJ, Vissink A, Schepers RH, Jansma J, Schortinghuis J. A Systematic Review of the Efficacy of Microfocused Ultrasound for Facial Skin Tightening. *Int J Environ Res Public Health.* 2023;20(2):1522. [doi:10.3390/ijerph20021522](https://doi.org/10.3390/ijerph20021522) · [PMID:36674277](https://pubmed.ncbi.nlm.nih.gov/36674277/) 5. Gülbitti HA, Colebunders B, Pirayesh A, Bertossi D, van der Lei B. Thread-Lift Sutures: Still in the Lift? A Systematic Review of the Literature. *Plast Reconstr Surg.* 2018;141(3):341e-347e. [doi:10.1097/PRS.0000000000004101](https://doi.org/10.1097/PRS.0000000000004101) · [PMID:29481392](https://pubmed.ncbi.nlm.nih.gov/29481392/) 6. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. *Clin Cosmet Investig Dermatol.* 2015;8:47-52. [doi:10.2147/CCID.S69118](https://doi.org/10.2147/CCID.S69118) · [PMID:25709486](https://pubmed.ncbi.nlm.nih.gov/25709486/) 7. Lim J, Siew TW, Xu Y. Early Experience With Ultherapy Prime in Asia Pacific: A Pilot Case Series. *Plast Reconstr Surg Glob Open.* 2025;13(11):e7269. [doi:10.1097/GOX.0000000000007269](https://doi.org/10.1097/GOX.0000000000007269) · [PMID:41282450](https://pubmed.ncbi.nlm.nih.gov/41282450/) ## MFU, MFU-V and HIFU: What Is Being Compared? Source: https://ultherapy-seoul.com/mfu-v-vs-hifu/ Updated: 2026-10-24 MFU means microfocused ultrasound; MFU-V adds visualization. HIFU means high-intensity focused ultrasound and describes a technology category, not one device. Ultherapy combines MFU with ultrasound imaging. Imaging is a feature of the named system; the term HIFU alone does not establish whether another device has it.[1] [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/) ### The shared physics Both Ultherapy and generic HIFU devices use focused ultrasound to deposit thermal energy at a defined depth below the skin surface, producing small zones of coagulation that subsequently trigger collagen remodeling. That much is common ground. The differences begin at the transducer, the visualization layer, and the regulatory file behind the device. ### The visualization layer The Ultherapy console displays a real-time B-mode ultrasound image of the tissue under the transducer before each line is fired: visualizing tissue planes to a depth of approximately 8 mm[1]. The image helps the operator assess tissue layers, skin contact and an appropriate treatment depth. Figure: Fine gold lines converge at glowing points on three curved layers against a navy background. Some HIFU devices do not include real-time tissue imaging. Features vary by model; confirm the exact device and its imaging capability before treatment. ### Transducer engineering Ultherapy uses transducers with nominal focal depths of 1.5, 3.0 and 4.5 mm. Each treatment line creates a sequence of thermal coagulation points. Other HIFU systems vary in transducer design, available depths and imaging capabilities. ### Regulatory pathway Ultherapy has historical US De Novo and 510(k) decisions for specified indications. [K260618](https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260618.pdf) includes additional body indications. Confirm the exact device and its applicable Korean labeling with the treating clinic. Figure: Ultherapy (MFU-V) and another HIFU device compared by imaging and focal depth Ultherapy images tissue to about 8 mm and focuses at nominal depths of 1.5, 3.0 and 4.5 mm; for another HIFU device, confirm the model's imaging and depths. ### Side-by-side at a glance The Ultherapy specifications are described in the US instructions for use. They do not supply specifications or comparative outcomes for every HIFU device. [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) | Comparison point | Ultherapy (MFU-V) | Other HIFU devices | | --- | --- | --- | | Imaging | Ultrasound imaging supports tissue and contact checks | Confirm the imaging capability of the named model | | Nominal focal depths | 1.5, 3.0 and 4.5 mm | Confirm the model and transducer specifications | | Comparative clinical outcomes | The cited trial compares MFU-V with monopolar RF[2] | Not tested as a comparator in that RF trial | ### How this plays out in Korean practice Compare the exact device and proposed plan. [Pricing](https://ultherapy-seoul.com/pricing-seoul/) depends on the areas treated and line count. Ask who will assess and treat you, which device will be used, and how depths and lines will be planned. Korean-made HIFU devices such as Shurink, Ultraformer and Doublo, and how to confirm the exact model, are covered in [a separate device guide](https://hifuseoul.com/guides/korean-hifu-devices-guide/). ### How to ask about device specifics at consultation A short list of useful questions: Which exact device is used and what is its KFDA registration number? How many transducers (1.5 / 3.0 / 4.5 mm) does the protocol include for my zone? How many lines are planned, and what is the line-count basis for the quoted price? Is there real-time visualization, and will the clinician adjust the plan based on what they see on the screen? Clinics that answer these questions plainly are easier to trust than clinics that deflect with marketing language. ### What controlled trials show against other modalities Direct head-to-head data exist. A randomized, split-face, evaluator-blind trial compared MFU-V on one side of the face against monopolar radiofrequency (MRF) on the other side in 20 subjects with mild-to-moderate laxity, followed for six months. Both modalities produced a significant improvement on the Fasil Face and Neck Laxity Grading Scale at day 30, with the gain sustained through days 90 and 180. There was no statistically significant difference between the two arms on the laxity scale or on patient satisfaction[2]. [Who is a good candidate](https://ultherapy-seoul.com/candidates-and-contraindications/) . The comparator was radiofrequency, not another HIFU device. This trial cannot establish that MFU-V is superior to HIFU, and a nonsignificant difference does not prove equivalence.[2] ### Where this leaves you MFU-V and other lifting treatments differ in their mechanism and evidence. Compare the proposed plan, expected benefit and risks. [Thread lifts](https://ultherapy-seoul.com/ultherapy-vs-thread-lift/) use suspension sutures rather than ultrasound energy. ### MFU-V in practice: interval, pain, recovery Three practical questions decide most MFU-V consultations. **How often?** A single session is standard; the clinician arranges result assessment before considering further treatment. **Does it hurt?** MFU-V delivers discrete thermal coagulation points, and pain management (topical anesthesia, pacing, depth selection) is part of the protocol: discomfort can occur during and after treatment. **What recovery?** Most people return to usual activity the same day; mild swelling may last 1–3 days, and visible changes develop gradually. Recovery effects and signs that should prompt a message to a treating clinic, is in the [aftercare and downtime guide](https://ultherapy-seoul.com/aftercare-downtime/). ### Risks and contraindications Redness, swelling, tenderness, bruising and altered sensation can occur. Postmarketing reports also include muscle weakness, burns, nodules and fat or volume loss; their frequency is uncertain. Discuss prior fillers and implants before treatment. In a 52-patient open-label trial across Fitzpatrick III–VI skin, the three reported adverse events resolved by day 90 without sequelae[4]. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. ### References 1. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. *Clin Cosmet Investig Dermatol.* 2015;8:47-52. [doi:10.2147/CCID.S69118](https://doi.org/10.2147/CCID.S69118) · [PMID:25709486](https://pubmed.ncbi.nlm.nih.gov/25709486/) 2. Alhaddad M, Wu DC, Bolton J, et al. A Randomized, Split-Face, Evaluator-Blind Clinical Trial Comparing Monopolar Radiofrequency Versus Microfocused Ultrasound With Visualization for Lifting and Tightening of the Face and Upper Neck. *Dermatol Surg.* 2019;45(1):131-139. [doi:10.1097/DSS.0000000000001653](https://doi.org/10.1097/DSS.0000000000001653) · [PMID:30531187](https://pubmed.ncbi.nlm.nih.gov/30531187/) 3. Vachiramon V, Pavicic T, Casabona G, et al. Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. *J Cosmet Dermatol.* 2024;24(2):e16658. [doi:10.1111/jocd.16658](https://doi.org/10.1111/jocd.16658) · [PMID:39501429](https://pubmed.ncbi.nlm.nih.gov/39501429/) 4. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/) ## Ultherapy Pricing in Seoul Source: https://ultherapy-seoul.com/pricing-seoul/ Updated: 2026-10-20 Ultherapy Prime at [Delight Dermatology Clinic](https://hifuseoul.com/pricing/#price-pricing-1-pricing-4) is ₩300,000–2,700,000 per session, depending on shot count. Confirm the treatment plan, included services and final tax-inclusive quote at consultation. Figure: Seoul cityscape Ultherapy cost depends on the treatment plan. For outcome evidence, see [is Ultherapy worth it](https://ultherapy-seoul.com/is-ultherapy-worth-it/). ### How a price is calculated The two main inputs are **line count** and **zone count**. A treatment line creates a sequence of thermal coagulation points at the selected depth; the three treatment depths are set out in [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/). A typical full-face session might involve 300 to 500 lines distributed across the cheek, jawline, and submental zones at depths of 3.0 mm and 4.5 mm, sometimes with additional 1.5 mm lines on the upper neck. Adding the lateral neck increases the count. Adding the décolletage increases it further. Some patients need a lighter touch-up of fewer than 200 lines; others, with more zones in play, are quoted higher. A second input is the **anesthesia plan**. Topical anesthetic cream is standard and usually included. Oral analgesia or an anxiolytic may be added for sensitive patients. Local nerve blocks delivered by the dermatologist are sometimes used for patients with very low pain tolerance and may carry a modest additional fee. A third point to confirm is the **device and transducers**. Price alone does not establish whether a quote is for Ultherapy (MFU-V) or [generic HIFU](https://ultherapy-seoul.com/mfu-v-vs-hifu/). Ask for the manufacturer and model, real-time ultrasound visualization, planned treatment areas and line count before comparing quotes. ### Treatment areas and planning Treatment areas and line counts are planned after examination. 1 tier Touch-up single zone ~100–200 lines Zones treated - Cheek Maintenance, or a very localised concern. 2 tier Full face full-face plan ~300–500 lines Zones treated - Cheek - Jawline - Submental A full-face plan for an initial assessment. 3 tier Full face + neck extended lifting ~500–700 lines Zones treated - Cheek - Jawline - Submental - Neck Adds the neck for patients with combined laxity. 4 tier Face + neck + décolletage comprehensive ~700–900+ lines Zones treated - Cheek - Jawline - Submental - Neck - Décolletage Comprehensive treatment in a single session. Treatment areas by zone plan. Ultherapy treatment areas | Zone plan | Planning | Coverage and line count | | --- | --- | --- | | Touch-up / single small zone | Individual treatment plan | A supplementary treatment after individual reassessment, or a very localised concern; ~100–200 lines. | | Full face | Individual treatment plan | Cheek, jawline, and submental zones at appropriate depths; ~300–500 lines: the most common booking. | | Full face + neck | Individual treatment plan | Adds the lateral and anterior neck; ~500–700 lines. Often the right choice for combined cheek and neck laxity. | | Full face + neck + décolletage | Individual treatment plan | Adds the upper chest, with treatment depths selected for the individual anatomy; ~700–900+ lines. | A guide to [Ultherapy prices in Seoul](https://hifuseoul.com/guides/ultherapy-price-seoul/) breaks down how shot count and treatment area change a quote. ### Services to confirm A typical MFU-V price covers the device session, the standard anesthesia plan, and the immediate post-treatment care that day. Optional add-ons such as a follow-up laser session, post-treatment LED therapy or take-home topicals are separate, and not assumed unless discussed. ## Ultherapy Before-and-After Photos: How to Judge What They Show Source: https://ultherapy-seoul.com/ultherapy-before-and-after-photos/ Updated: 2026-10-18 An Ultherapy before-and-after pair shows one person in two photographs. Standardized photographs help assess visible change in the person shown. They do not establish your likely result; interpreting study outcomes also requires information about patient selection, other treatments and follow-up. In studies where masked raters compared standardized photographs, measured changes were small, such as an average brow elevation of 1.7 mm at day 90[1], and in several studies blinded improvement rates were lower than patients' or physicians' own ratings[2,3,4]. Check the conditions of the two photographs before reading the difference between them as a result. Figure: Two identical empty white picture frames side by side on a wall under matched lighting ### What one photo pair can show If the photographs are comparable, a pair can show that one person's appearance changed between two moments. It cannot show how often a similar change happens, how large it is for other people or how long it lasts. Estimating frequency and duration requires group data and repeated follow-up. The US Federal Trade Commission's staff [Health Products Compliance Guidance](https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance) (December 2022) draws the same line. It says individual consumer experiences are never sufficient to substantiate claims about a health product's effects, and that testimonials reporting results more dramatic than users can generally expect are likely to be deceptive. One worked example, an ad for a weight-loss supplement, pairs before-and-after photographs with a customer's accurate account of her result; the guidance finds that a fine-print disclaimer does not tell readers that their own result is likely to be much smaller. ### What to check in a before-and-after set Technical guidelines for applying the International Skin Imaging Collaboration's dermatological imaging standards list the conditions to standardize before skin images can be compared: lighting, background color, field of view, image orientation, focus and depth of field, resolution, and scale and color calibration[5]. They were written for dermatology imaging in general rather than for galleries. Figure: Empty photo studio with a camera on a tripod, a softbox light and a wooden stool in front of a plain grey backdrop The same lighting, camera position and backdrop for both photos. - **Matching conditions.** Check that lighting, camera position, expression, posture and processing match[5]. - **Selection and blinding.** Ask who selected the photographs and what information assessors were blinded to. - **Follow-up day.** The second photo should state the day after treatment. One rater-blinded study took standardized front and side photographs at days 2, 7, 28, 60 and 90[1]. That study reported mild, short-lived redness and swelling as common, so a photo from the first days may show swelling rather than the gradual change. Recovery is described under [aftercare and downtime](https://ultherapy-seoul.com/aftercare-downtime/). - **Number of patients.** Ask how many patients with a similar starting point were treated and how many photo sets exist. ### What masked-rater studies found The studies below report photographic assessments by masked, or blinded, raters alongside other ratings. Figure: Blank white photo prints spread on a wooden desk beside a magnifying glass and a closed notebook The studies below rated paired photographs. - In a 2010 rater-blinded cohort study of an investigational focused ultrasound device, three physician raters who were not study authors compared photographs taken before treatment and at day 90. They judged 30 of 35 participants (86%) to show a clinically significant brow lift; the average measured brow elevation was 1.7 mm. The authors could not quantitatively measure lower-face tightening because that area lacks fixed anatomical landmarks[1]. - In a retrospective study of women treated with MFU-V, physicians rated 77.7% as improved at 180 days on a global aesthetic scale, while blinded reviewers judged 67% to show improvement in appearance[2]. - In a 20-person MFU-V pilot, 95% were rated improved on physician and patient global aesthetic scales at one year, while blinded assessment rated 6 of 14 evaluable participants as improved at that point[3]. - Two blinded dermatologists comparing paired lower-face photographs scored 20.9% as improved, 62.5% as unchanged and 16.7% as worse, while 45.9% of patients reported improvement. A 24-patient study using Microson, a different ultrasound device, reported these ratings at a median 4.3 months[4,6]. These are not Ultherapy-specific outcome rates. - A 2023 systematic review of 16 studies with predominantly female participants, using several ultrasound devices, reported measured brow lifts of 0.47–1.7 mm and submental reductions of 26–45 mm² on side-view photographs, and called for more objective outcome measures[6]. These studies reported small measured changes and differences between photographic and participant ratings. ### What two FDA records show about photographs Two of the Ulthera System's US 510(k) records include applicant-written summaries of the clinical data behind an added indication. Both relied on photographs. The [K121700 summary](https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121700.pdf) (cleared October 2, 2012) covers lifting lax submental and neck tissue. It reports that 51 of 70 patients reached a measured lift of at least 20 mm², and that masked evaluators identified improvement in 84.3% of those 51. The [K134032 summary](https://www.accessdata.fda.gov/cdrh_docs/pdf13/K134032.pdf) (cleared June 20, 2014) covers lines and wrinkles of the décolletage. It states that the planned wrinkle scale could not be validated because its intra-rater and inter-rater reproducibility were low. The primary endpoint was changed to a post-hoc masked assessment of before and after photographs, with no success criteria set in advance. Of 108 per-protocol participants, 54 day-180 photo sets were set aside for inconsistencies including changes in lighting, color, focus, patient positioning and cropping. In the remaining 54, masked assessment recorded 36 (about 67%) as improved, 13 (24%) as "incorrect" and 5 (9%) as no change; the summary does not define the "incorrect" category further. Figure: Checklist diagram: two identically set up empty photo frames with the same light direction, distance, level head line, scale and color reference, beside questions to ask about a photo set Checklist based on clinical-photography guidance and the K134032 summary. A gallery that does not say how its photographs were taken gives no way to know whether they would have passed that screen. The wider US regulatory history is covered in [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/). ### Photos in Korean medical advertising Article 56 of Korea's [Medical Service Act](https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%98%EB%A3%8C%EB%B2%95/%EC%A0%9C56%EC%A1%B0) lists kinds of medical advertising that medical providers may not run. They include advertising, such as patients' accounts of their treatment, that may lead consumers to misunderstand treatment effects; advertising that leaves out important information such as serious side effects; and advertising that exaggerates objective facts. ### Questions to ask about a clinic's photos 1. On what day after treatment was the second photo taken? 2. Were both photos taken with the same lighting, camera distance and pose? 3. Has either image been filtered, retouched or cropped differently? 4. How many patients with a starting point like mine have photo sets, and how was this one chosen? 5. Who judged the change, and did they know which photo came first? 6. Will you photograph me the same way at baseline and at follow-up? For comparison, [Delight Dermatology Clinic’s before-and-after section](https://hifuseoul.com/procedures/ultherapy-seoul/#procedure-before-after) shows how one clinic presents its result photographs. ### Common questions ### Are Ultherapy before-and-after photos proof that the treatment works? A before-and-after pair documents one person in two photographs. Evidence about how often and how much change occurs comes from groups of patients photographed under standardized conditions at stated follow-up days and assessed by raters who did not know which photo came first. ### When is an Ultherapy after photo meaningful? When it states the day after treatment and matches the before photo in lighting, camera angle and distance, expression, crop and editing. Studies used fixed follow-up points such as day 90 or day 180, and photos from the first days can include short-lived redness or swelling. ### Why might photos show less change than I feel? Blinded dermatologists comparing paired lower-face photographs scored 20.9% as improved, while 45.9% of patients reported improvement. A 24-patient study using Microson, a different ultrasound device, reported these ratings at a median 4.3 months. The authors suggested that photographs may not capture everything patients notice. ### Device records and guidance 1. US Food and Drug Administration. [K121700: Ulthera System](https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121700.pdf), 510(k) summary and decision letter, October 2, 2012. 2. US Food and Drug Administration. [K134032: Ulthera System](https://www.accessdata.fda.gov/cdrh_docs/pdf13/K134032.pdf), 510(k) summary and decision letter, June 20, 2014. 3. US Federal Trade Commission. [Health Products Compliance Guidance](https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance), December 2022, sections III.B.2 and III.C.1. 4. Republic of Korea. [Medical Service Act, Article 56](https://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%9D%98%EB%A3%8C%EB%B2%95/%EC%A0%9C56%EC%A1%B0), National Law Information Center, text in force from October 2, 2026. ### References 1. Alam M, White LE, Martin N, et al. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. *J Am Acad Dermatol.* 2010;62(2):262-9. [doi:10.1016/j.jaad.2009.06.039](https://doi.org/10.1016/j.jaad.2009.06.039) · [PMID:20115948](https://pubmed.ncbi.nlm.nih.gov/20115948/) 2. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) 3. Werschler WP, Werschler PS. Long-term Efficacy of Micro-focused Ultrasound with Visualization for Lifting and Tightening Lax Facial and Neck Skin Using a Customized Vectoring Treatment Method. *J Clin Aesthet Dermatol.* 2016;9(2):27-33. [PMID:27047630](https://pubmed.ncbi.nlm.nih.gov/27047630/) 4. Yalici-Armagan B, Elcin G. Evaluation of microfocused ultrasound for improving skin laxity in the lower face: A retrospective study. *Dermatol Ther.* 2020;33(6):e14132. [doi:10.1111/dth.14132](https://doi.org/10.1111/dth.14132) · [PMID:32770566](https://pubmed.ncbi.nlm.nih.gov/32770566/) 5. Finnane A, Curiel-Lewandrowski C, Wimberley G, et al. Proposed Technical Guidelines for the Acquisition of Clinical Images of Skin-Related Conditions. *JAMA Dermatol.* 2017;153(5):453-457. [doi:10.1001/jamadermatol.2016.6214](https://doi.org/10.1001/jamadermatol.2016.6214) · [PMID:28241182](https://pubmed.ncbi.nlm.nih.gov/28241182/) 6. Contini M, Hollander MHJ, Vissink A, Schepers RH, Jansma J, Schortinghuis J. A Systematic Review of the Efficacy of Microfocused Ultrasound for Facial Skin Tightening. *Int J Environ Res Public Health.* 2023;20(2):1522. [doi:10.3390/ijerph20021522](https://doi.org/10.3390/ijerph20021522) · [PMID:36674277](https://pubmed.ncbi.nlm.nih.gov/36674277/) ## Ultherapy Fat Loss and Other Reported Risks: What Records and Studies Show Source: https://ultherapy-seoul.com/ultherapy-fat-loss/ Updated: 2026-10-24 Fat or volume loss is on the list of adverse events that the Ulthera System instructions for use record from routine clinical use and from the literature on micro-focused ultrasound. In the published literature, a 2025 systematic review found 1 case of subcutaneous atrophy across 19 articles covering 506 patients, while lipoatrophy was among the events reported most often in 106 records from the US FDA MAUDE device-report database[1]. How much fat a face has, and the depth chosen for each area, are planning questions to raise at consultation. Figure: Two dot grids with one dot per patient: 1 case of subcutaneous atrophy among 506 patients in 19 articles in a 2025 adverse-event review, and 14 of 573 patients in 16 studies (2%) with effects other than pain and transient redness or swelling in a 2023 review of facial tightening ### What the instructions for use list The [Ulthera System instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) separate two kinds of evidence. Section 2.5 lists the side effects seen in the clinical evaluation of brow, under-chin and neck treatments and calls them mild and transient: redness, swelling, welting, pain, bruising and nerve effects. Burns, sometimes with scarring, are listed as possible with incorrect technique, such as a tilted transducer, incorrect line spacing or gel pockets. Section 2.7, on post-market safety, lists events identified during routine clinical use of the system and in the wider literature on micro-focused ultrasound devices. Under skin and soft tissue it includes fat/volume loss, skin sagging or drooping, asymmetry, nodules, burns or blisters, pigmentary change and scarring. Because these events are reported voluntarily from a population of uncertain size, the document says it is not always possible to reliably estimate their frequency or establish a causal relationship to the system. ### What studies and device reports show - **Systematic review of adverse events, 2025.** The authors searched PubMed for MFU-V adverse events, fat loss and facelifts, and the US Food and Drug Administration's MAUDE database under the brand name Ulthera. The 19 articles covered 506 patients; transient swelling, redness and pain after the procedure were seen most often, and significant treatment-related events were limited apart from 1 case of subcutaneous atrophy. Among the 106 MAUDE records, lipoatrophy, neurologic effects and scarring were reported most frequently, and 1 record described facelift compromise. The authors describe the facelift reports as anecdotal and largely unverified[1]. - **Systematic review of facial tightening, 2023.** Of 16 studies of a single microfocused ultrasound treatment, 11 used the Ulthera system. Effects other than pain and transient redness or swelling were noted in 14 of 573 treated patients (2%): bruising, transient dysesthesia, a wheal, skin burns, white linear striae of the neck and dermal white papules[2]. Figure: Three panels: published studies, 19 articles with 506 patients and 1 case of subcutaneous atrophy; US FDA MAUDE reports, 106 records with lipoatrophy, nerve effects and scarring reported most often; the manufacturer’s post-market list, which includes fat or volume loss Counts as stated in a 2025 systematic review and the instructions for use. A 2025 letter to the editor by Kim and Choi measured one case with MRI. A 32-year-old man had one Ultherapy Prime session to the midface, 240 shots at 0.9 J at 4.5 mm and 380 shots at 0.35 J at 3.0 mm, while his body mass index moved from 23.0 to 23.3. Three months later, most treated areas showed thinner superficial fat, and the SMAS was about 0.1 mm thicker. The authors could not tell whether the thinner fat reflected tightening of the retinacula cutis, the fibrous strands that run through the fat, or fat breakdown. They recommend real-time ultrasound guidance to avoid placing too many heated points in that layer, especially in patients predisposed to lipoatrophy[3]. Figure: Bar chart of superficial fat thickness in millimeters at six midface sites in one man, before and 3 months after Ultherapy Prime: upper medial 6.68 to 5.69, lower medial 8.33 to 6.71, upper middle 10.08 to 8.52, lower middle 8.19 to 6.01, upper lateral 6.18 to 6.31, lower lateral 4.84 to 3.87 MRI measurements from a single case. ### Facial fat, body weight and treatment planning Studies of microfocused ultrasound often excluded people with excess subcutaneous fat or a body mass index above 30, and two studies linked a lower body mass index with better outcomes, one reporting higher patient-rated improvement at 25 or below[2]. The instructions for use discuss thin fat in their section on the arms and knees: patients with a low body mass index may have below-normal fat relative to skin, which may increase the risk of injury to nerves and vessels of the arm, and significant weight loss may leave a thin fat layer and stretched anatomy. A 2019 review proposed five planning steps for microfocused ultrasound: assess, decide which depth, select the number of lines, plan any combination and treat. Its authors name visualization with ultrasound and real-time evaluation of structural changes, such as bone or fat loss, as the two most important tools for precision and efficacy[4]. The instructions for use describe the imaging as a way to see the dermal and subdermal layers, check that the transducer is coupled to the skin and confirm an appropriate treatment depth, such as one that avoids bone. Figure: Flow of five planning steps: assess expectations and facial features, decide which depth, select the number of lines, plan any combination, then treat with documentation, safety and comfort The five planning steps proposed in a 2019 review of microfocused ultrasound. ### Nerve effects, burns and technique From the clinical evaluation, the instructions for use list transient local muscle weakness and numbness that may follow inflammation of a motor or sensory nerve, typically resolving in 2 to 6 weeks. Their post-market list of neurological events includes numbness, paresthesia, palsy or paresis, speech difficulty, headache or migraine and vision changes, and notes that nerve effects lasting for months have been described. Several warnings in the instructions concern technique: too much or too little gel obstructs skin contact, improper coupling of the transducer could cause adverse events, and delivering lines without adequate spacing could overheat tissue. Pain during and after a session is covered in [does Ultherapy hurt](https://ultherapy-seoul.com/does-ultherapy-hurt/), and conditions that rule treatment out in [candidates and contraindications](https://ultherapy-seoul.com/candidates-and-contraindications/). ### Questions to ask at the consultation 1. Will you look at my fat layer on the ultrasound image before choosing depths, and where is it thin? 2. Which depths and how many lines will you use in each area, and why? 3. Are there areas you would treat less or leave out because the fat there is thin? 4. Will the depths, line counts and energy levels be written in my record? 5. Whom do I contact if I notice a dent, numbness or weakness afterwards? [Delight Dermatology Clinic's description of depth planning with imaging](https://hifuseoul.com/procedures/ultherapy-seoul/#procedure-devices) shows how one Seoul clinic presents this step. ### Common questions ### Can Ultherapy cause fat loss? Fat or volume loss is listed in the post-market safety section of the Ulthera System instructions for use. A 2025 systematic review found 1 case of subcutaneous atrophy in 19 published articles covering 506 patients, and lipoatrophy was among the events reported most often in 106 records from the US FDA MAUDE device-report database. ### Can Ultherapy cause nerve damage? The instructions for use list transient muscle weakness and numbness that may follow inflammation of a nerve, typically resolving in 2 to 6 weeks. Their post-market section adds palsy, paresis and speech difficulty and notes that nerve effects lasting for months have been described. In 106 MAUDE records analyzed in a 2025 systematic review, nerve damage, focal numbness, dysesthesia and ptosis were among the events reported most often. ### What did the MRI case show about fat after Ultherapy? In one 32-year-old man scanned before and 3 months after an Ultherapy Prime session to the midface, most treated areas showed thinner superficial fat, and the SMAS was about 0.1 mm thicker. ### Device document 1. Ulthera, Inc. [Ulthera System Instructions for Use, featuring DeepSEE technology for Ultherapy PRIME](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf), document 1016413IFU Rev00, 2026: sections 2.1, 2.5.1, 2.7, 6.2, 7.3.4 and 7.3.5. ### References 1. Humphrey VS, Rambhia PH, Gmyrek R, Chapas A. Microfocused Ultrasound With Visualization: A Systematic Review of Adverse Events and Risk of Subsequent Facelift Compromise. *Dermatol Surg.* 2025;51(4):424-429. [doi:10.1097/DSS.0000000000004510](https://doi.org/10.1097/DSS.0000000000004510) · [PMID:39625163](https://pubmed.ncbi.nlm.nih.gov/39625163/) 2. Contini M, Hollander MHJ, Vissink A, Schepers RH, Jansma J, Schortinghuis J. A Systematic Review of the Efficacy of Microfocused Ultrasound for Facial Skin Tightening. *Int J Environ Res Public Health.* 2023;20(2):1522. [doi:10.3390/ijerph20021522](https://doi.org/10.3390/ijerph20021522) · [PMID:36674277](https://pubmed.ncbi.nlm.nih.gov/36674277/) 3. Kim JH, Choi WS. MRI-Based Assessment of Microfocused Ultrasound-Induced Midface Lifting. *J Cosmet Dermatol.* 2025;24(10):e70477. [doi:10.1111/jocd.70477](https://doi.org/10.1111/jocd.70477) · [PMID:41118446](https://pubmed.ncbi.nlm.nih.gov/41118446/) 4. Casabona G, Kaye K. Facial Skin Tightening With Microfocused Ultrasound and Dermal Fillers: Considerations for Patient Selection and Outcomes. *J Drugs Dermatol.* 2019;18(11):1075-1082. [PMID:31738490](https://pubmed.ncbi.nlm.nih.gov/31738490/) ## Ultherapy for Men: What Is Actually Different Source: https://ultherapy-seoul.com/ultherapy-for-men/ Updated: 2026-10-24 Ultherapy® (MFU-V) uses the same mechanism in men and women: focused ultrasound triggers new collagen and elastin over 2–3 months. Published follow-up does not establish one duration for every patient. Most people resume usual activity the same day, but temporary redness, swelling, tenderness, bruising, numbness or altered sensation can occur. What differs is the planning: male facial tissue is treated with customised line counts and depth sequencing, and Korean clinicians have published male-specific MFU-V protocols. One honest caveat: most published MFU-V efficacy studies enrolled female patients, so male expectations are set individually at consultation. Figure: Zones men most often want treated: brow, jawline, submental area and lateral neck The device and the science are the same; the treatment plan is what gets tailored to a male face. Non-surgical lifting is no longer a treatment men ask about quietly. Demand among male patients has grown, and the questions are practical: will it look natural, is there downtime, and does it actually work on a heavier male jawline. The short answer is that MFU-V is the same technology regardless of sex: the mechanism, depths, US FDA De Novo classification and later 510(k) clearances are covered on [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/): but the treatment planning is where male-specific judgment comes in. ### What is different in male patients Male facial skin tends to be thicker and the underlying tissue denser, and male aging concentrates in slightly different zones: the jawline, the submental area under the chin, the lateral neck, and the brow. Because of this, the treatment is not simply the female protocol applied to a male face. Korean dermatologists have described customising MFU-V specifically for Asian male facial anatomy, adjusting line counts and depth sequencing to the male tissue and the zones men most often want addressed[1]. The visualization layer that defines MFU-V is part of why this customisation is possible: the clinician sees the tissue before each line is delivered. The goal for most male patients is a firmer jaw and neck line rather than a dramatic change: and MFU-V's gradual, collagen-driven result suits that aim, since the change builds quietly over weeks rather than appearing overnight. ### What the evidence does (and does not) show for men It is worth being candid here. A systematic review of MFU-V for facial skin tightening found that the controlled studies to date were conducted almost entirely in female patients, and the authors specifically identified male patients as a priority for future research[2]. That does not mean MFU-V fails in men: the mechanism is identical and the Korean male-specific clinical experience is encouraging[1]: but it does mean a male patient should expect his plan and expectations to be set individually rather than from large male-only trial data that does not yet exist. MFU-V remains the reference standard for focused-ultrasound skin lifting overall[4]. ### What men can expect: at a glance | Aspect | For male patients | | --- | --- | | **Common treatment zones** | Jawline, submental area, lateral neck, brow | | **Protocol** | Line count and depth sequencing customised to male facial tissue | | **Timeline to result** | Gradual change; reassess around 2–3 months | | **How long it lasts** | Study follow-up often reaches 180 days; duration varies individually | | **Downtime** | Essentially none; mild redness or swelling settles quickly | | **Evidence base** | Predominantly female trials; emerging male-specific Korean experience | Published MFU-V outcome data document improvement at 180 days[3]. Some small studies report selected measures to 9–12 months, but no universal duration is established. ### Safety and suitability The safety profile is the same as for any MFU-V patient: an open-label trial across Fitzpatrick III–VI skin reported three adverse events that all resolved by day 90, with the usual transient redness and swelling[5]. Suitability follows the same candidacy logic as well: mild-to-moderate laxity responds most favorably, and advanced laxity is better served by surgical consultation[6]. The full criteria, including contraindications, are on the [candidates and contraindications](https://ultherapy-seoul.com/candidates-and-contraindications/) page, and if you are weighing energy against a physical implant, the [Ultherapy vs thread lift](https://ultherapy-seoul.com/ultherapy-vs-thread-lift/) comparison may help. For how a male treatment plan is built in practice, see [Delight Dermatology Clinic's consultation and planning steps](https://hifuseoul.com/procedures/ultherapy-seoul/#procedure-process); the recovery side is detailed on the [aftercare and downtime](https://ultherapy-seoul.com/aftercare-downtime/) page. ### Risks and contraindications Redness, swelling, tenderness, bruising and altered sensation can occur. Postmarketing reports also include muscle weakness, burns, nodules and fat or volume loss; their frequency is uncertain. Discuss prior fillers and implants before treatment. In a 52-patient open-label trial across Fitzpatrick III–VI skin, the three reported adverse events resolved by day 90 without sequelae[5]. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. ### References 1. Park JY, Hong W, Lee KC, et al. Customizing Microfocused Ultrasound With Visualization Treatment for Facial Lifting in Asian Men: Experience and Practical Insights From Korea. *J Cosmet Dermatol.* 2025;24(6):e70278. [doi:10.1111/jocd.70278](https://doi.org/10.1111/jocd.70278) · [PMID:40488260](https://pubmed.ncbi.nlm.nih.gov/40488260/) 2. Contini M, Hollander MHJ, Vissink A, Schepers RH, Jansma J, Schortinghuis J. A Systematic Review of the Efficacy of Microfocused Ultrasound for Facial Skin Tightening. *Int J Environ Res Public Health.* 2023;20(2):1522. [doi:10.3390/ijerph20021522](https://doi.org/10.3390/ijerph20021522) · [PMID:36674277](https://pubmed.ncbi.nlm.nih.gov/36674277/) 3. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) 4. Vachiramon V, Pavicic T, Casabona G, et al. Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. *J Cosmet Dermatol.* 2024;24(2):e16658. [doi:10.1111/jocd.16658](https://doi.org/10.1111/jocd.16658) · [PMID:39501429](https://pubmed.ncbi.nlm.nih.gov/39501429/) 5. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/) 6. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. *Clin Cosmet Investig Dermatol.* 2015;8:47-52. [doi:10.2147/CCID.S69118](https://doi.org/10.2147/CCID.S69118) · [PMID:25709486](https://pubmed.ncbi.nlm.nih.gov/25709486/) ## Ultherapy in Summer: Sun Exposure, Tanning and Timing Source: https://ultherapy-seoul.com/ultherapy-in-summer/ Updated: 2026-10-18 Ultherapy® (MFU-V) is a year-round treatment. The focused ultrasound is delivered beneath the skin surface and does not target melanin, so summer sun exposure or a recent light tan does not rule it out the way it can for many light-based treatments: safety is documented across Fitzpatrick skin types III–VI. Most people resume usual activity the same day, but temporary redness, swelling, tenderness, bruising, numbness or altered sensation can occur. Daily broad-spectrum SPF 30+ remains important, and treatment is postponed on sunburned or inflamed skin. Result assessment is commonly planned around 8–12 weeks after the actual treatment date. Figure: Seoul city skyline on a clear day Unlike surface-targeting treatments, focused ultrasound does not have an off-season. "Should I wait until winter?" is one of the most common scheduling questions in aesthetic dermatology, and for many treatments it is the right question: resurfacing lasers, peels, and other pigment- or surface-targeting procedures genuinely are harder to plan around strong sun. MFU-V targets deeper tissue rather than surface pigment. ### Why summer does not rule out MFU-V MFU-V delivers focused ultrasound to precise depths of 1.5, 3.0 and 4.5 mm, creating small thermal coagulation points in the dermis and SMAS while leaving the skin surface intact[1]. Nothing about that mechanism depends on melanin or any other surface chromophore. That is why the device's safety profile holds across darker and more sun-exposed skin: in a 52-patient open-label trial spanning Fitzpatrick phototypes III–VI, the three reported adverse events all resolved by day 90 without sequelae[2], and 180-day outcome data found no association between result and Fitzpatrick skin type[3]. Treatments that target pigment or disrupt the skin surface (ablative and fractional resurfacing, IPL, many pigment lasers) are commonly deferred on tanned skin because extra epidermal melanin raises the risk of pigmentary complications. MFU-V does not interact with the surface that way, which is the practical reason Korean clinics treat with it through July and August without a seasonal pause. ### A tan is not a sunburn The distinction that matters at consultation is between pigment and inflammation. A settled, even tan is pigment; it does not change how focused ultrasound behaves. An active sunburn is inflammation: red, tender, possibly peeling skin is a compromised barrier, and a responsible clinician will postpone treatment until it has fully settled rather than treat over it. If you have had heavy recent sun exposure, disclose it during the consultation or an optional photo review; it is one of the temporary factors, like an active skin infection, that shifts scheduling rather than candidacy itself. The durable candidacy criteria are covered in [candidates and contraindications](https://ultherapy-seoul.com/candidates-and-contraindications/). ### What actually changes in summer aftercare | Summer factor | Guidance | Why | | --- | --- | --- | | **Sun and SPF** | Broad-spectrum SPF 30+ daily; hat for long outdoor days | UV works against the new collagen the treatment is building: sun protection is the single most result-protective habit | | **Saunas, jjimjilbang, hot yoga** | Avoid for 24–48 hours after treatment | Added heat can prolong the mild swelling phase | | **Pools and the sea** | Fine once the post-treatment flush settles: usually same or next day | The skin surface is intact; there is no wound to protect from water | | **Exercise and sweating** | Normal activity the same day; intense heat exposure follows the 24–48 hour rule | Sweat itself is not a problem on intact skin | Everything else about recovery is season-independent: mild flush for a few hours, possible mild swelling for one to three days, and tenderness lasting up to two weeks or sensory changes lasting two to six weeks. The week-by-week detail, including skincare steps and when to contact the clinic, is on the [aftercare and downtime page](https://ultherapy-seoul.com/aftercare-downtime/). ### Timing after a summer session Changes develop over the months after treatment. In a pooled meta-analysis, roughly 77% of patients showed improvement at 90 days[4]; a separate study documented improvement at 180 days[3]. Discuss the treatment date and result review interval when planning for an event. A result at a fixed calendar date cannot be assured. ### Coming to Seoul in the summer Most people resume usual activities promptly, but visible redness, swelling or bruising can affect travel plans. Allow flexibility for discomfort and any follow-up requested by the clinician. Avoiding intense heat for 24–48 hours is one aftercare measure, alongside sun protection and care of sensitive skin. Before booking flights, [a treatment-and-flight planning guide](https://hifuseoul.com/guides/downtime-planning-seoul/) sets out typical recovery windows by treatment. A general booking needs no photograph; an optional photo and medication review can support preliminary planning but does not replace an in-person examination. ### Common summer questions ### Can I get Ultherapy if I already have a tan? Usually, yes. MFU-V delivers focused ultrasound beneath the skin surface and does not target melanin, so a tan is not the barrier it is for many light-based treatments: safety has been demonstrated across Fitzpatrick skin types III–VI. An active sunburn is different: inflamed, peeling skin is a reason to postpone until it has settled. Mention any heavy recent sun exposure at consultation. ### Can I go out in the sun after Ultherapy? Yes, the same day. MFU-V does not wound the skin surface, so it does not create the photosensitive recovery window that resurfacing treatments do. Broad-spectrum SPF 30+ every day is still the standard advice: not because the treatment made the skin fragile, but because ongoing UV exposure works against the collagen the treatment is building. ### Can I swim or use a sauna after Ultherapy? Swimming in a pool or the sea is fine once any post-treatment flush has settled, usually the same day or the next. Saunas, jjimjilbang, steam rooms and hot yoga are one aftercare consideration: avoid them for 24–48 hours, because added heat can prolong the mild swelling phase. ### Is summer a reasonable time to schedule Ultherapy? As reasonable as any season. Results develop over the following months; assessment is commonly planned around 8–12 weeks after treatment. Most people resume usual activity the same day, but temporary redness, swelling, tenderness or altered sensation can affect travel comfort; leave flexibility in the itinerary. ### Risks and contraindications Ultherapy® (MFU-V) is well tolerated when performed by a trained dermatologist, but it is not risk-free in any season. Common transient effects include redness and warmth (resolves in hours), mild swelling at 1–3 days, and occasional bruising at the jawline. Reported adverse events include temporary numbness in a specific facial zone, transient weakness of a facial muscle, and small areas of skin sensitivity. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. An active sunburn in the treatment area is a temporary reason to postpone. ### References 1. Vachiramon V, Pavicic T, Casabona G, et al. Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. *J Cosmet Dermatol.* 2024;24(2):e16658. [doi:10.1111/jocd.16658](https://doi.org/10.1111/jocd.16658) · [PMID:39501429](https://pubmed.ncbi.nlm.nih.gov/39501429/) 2. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/) 3. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) 4. Ling J, Zhao H. A Systematic Review and Meta-Analysis of the Clinical Efficacy and Patients' Satisfaction of Micro-focused Ultrasound (MFU) Treatment for Facial Rejuvenation and Tightening. *Aesthetic Plast Surg.* 2023;47(5):1806-1823. [doi:10.1007/s00266-023-03384-1](https://doi.org/10.1007/s00266-023-03384-1) · [PMID:37198297](https://pubmed.ncbi.nlm.nih.gov/37198297/) ## Ultherapy for the Jawline and Neck: Evidence and Assessment Source: https://ultherapy-seoul.com/ultherapy-jawline-and-neck/ Updated: 2026-10-18 The jawline is the contour along the lower jaw; the submental area is beneath the chin, and the neck is a separate region. MFU-V studies have assessed facial and neck laxity, including outcomes at 180 days. Whether a treatment plan fits these areas requires an assessment of anatomy and skin laxity.[2] Figure: Gold dotted curves converge on a glowing point between wavy ivory layers on a navy background. [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/) ### Anatomy and treatment depth Ultherapy transducers have nominal focal depths of 1.5, 3.0 and 4.5 mm. A depth setting does not identify the same tissue layer in every person or treatment area. Ultrasound imaging helps assess tissue layers, contact and an appropriate depth.[4] [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) | Specification | What it means | What to assess | | --- | --- | --- | | 1.5, 3.0, 4.5 mm | Nominal focal depths of the transducers | The tissue present at that depth in the proposed area | | Ultrasound imaging | Visualization of dermal and subdermal tissue | Contact and appropriate depth, including avoiding bone | | Anatomical area | Jawline, under-chin area and neck are distinct | The specific concern and treatment boundaries | ### US indications and local assessment The 2012 US clearance covers lifting lax submental and neck tissue. This historical decision is not a separate jawline-contouring indication or a statement of Korean authorization. Confirm local labeling for the exact device. [FDA K121700 (2012)](https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121700.pdf) ### What the evidence shows for the lower face and neck The Fabi 2014 evaluation documented MFU-V improvement at 180 days[2]. A study of 19 women used two HIFU sessions and six low-fluence Q-switched Nd:YAG laser sessions for neck and chest concerns, with improved scores and 84% satisfaction at week 16[1]. These HIFU findings do not establish outcomes for an MFU-V combination. [How to assess before-and-after photographs](https://ultherapy-seoul.com/ultherapy-before-and-after-photos/) ### Individual assessment Fabi’s review describes mild-to-moderate skin and soft-tissue laxity as a potential treatment setting. Severe laxity or marked platysmal bands warrants discussion of surgical options. A consultation should distinguish loose skin, fullness and muscle bands before setting expectations.[4] To see where the transducer is placed, watch [how Ultherapy is applied under the chin and on the neck](https://hifuseoul.com/videos/ultherapy-seoul/). [candidates and contraindications](https://ultherapy-seoul.com/candidates-and-contraindications/) [Ultherapy vs thread lift](https://ultherapy-seoul.com/ultherapy-vs-thread-lift/) [aftercare and downtime](https://ultherapy-seoul.com/aftercare-downtime/) [pricing](https://ultherapy-seoul.com/pricing-seoul/) ### Risks and contraindications Redness, swelling, tenderness, bruising and altered sensation can occur. Postmarketing reports also include muscle weakness, burns, nodules and fat or volume loss; their frequency is uncertain. Discuss prior fillers and implants before treatment. In a 52-patient open-label trial across Fitzpatrick III–VI skin, the three reported adverse events resolved by day 90 without sequelae[3]. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. ### References 1. Nam JH, Choi YJ, Lim JY, Min JH, Kim WS. Synergistic effect of high-intensity focused ultrasound and low-fluence Q-switched Nd:YAG laser in the treatment of the aging neck and décolletage. *Lasers Med Sci.* 2017;32(1):109-116. [doi:10.1007/s10103-016-2092-7](https://doi.org/10.1007/s10103-016-2092-7) · [PMID:27766442](https://pubmed.ncbi.nlm.nih.gov/27766442/) 2. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) 3. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/) 4. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. *Clin Cosmet Investig Dermatol.* 2015;8:47-52. [doi:10.2147/CCID.S69118](https://doi.org/10.2147/CCID.S69118) · [PMID:25709486](https://pubmed.ncbi.nlm.nih.gov/25709486/) 5. Vachiramon V, Pavicic T, Casabona G, et al. Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. *J Cosmet Dermatol.* 2024;24(2):e16658. [doi:10.1111/jocd.16658](https://doi.org/10.1111/jocd.16658) · [PMID:39501429](https://pubmed.ncbi.nlm.nih.gov/39501429/) ## Ultherapy PRIME vs Ultherapy: What Actually Changed? Source: https://ultherapy-seoul.com/ultherapy-prime-vs-ultherapy/ Updated: 2026-10-18 Ultherapy PRIME is documented as a newer console for the Ulthera System, not as a new clinical outcome claim. In the US FDA's 2024 510(k) record, PRIME and the earlier predicate use identical ultrasound signal energy and treatment guidelines, with the same intended use, indications, main components and imaging mode. The documented changes concern the console design, display, interface and updated hardware. The FDA record does not show that PRIME produces a better clinical result. Figure: Two equally clear abstract display frames with matching contour lines and a sound-wave card between them Ultherapy PRIME and earlier-console comparison. Searches for “Ultherapy PRIME vs Ultherapy” often mix together three separate questions: whether the treatment changed, whether the operator experience changed, and whether patients should expect a better outcome. The public records answer the first two. They do not establish the third. ### The documented differences at a glance | Question | Ultherapy PRIME | Earlier Ulthera console | | --- | --- | --- | | **510(k) summary comparison** | Subject device in K233996 | Predicate device K180623 | | **Intended use and US indications** | Same in the 510(k) summary comparison | Same in the 510(k) summary comparison | | **Ultrasound delivery** | Identical signal energy and treatment guidelines | Identical signal energy and treatment guidelines | | **Main components** | Console, handpiece and interchangeable transducers | Console, handpiece and interchangeable transducers | | **Imaging mode** | Same mode for visualizing the treatment area and supporting transducer contact | Same mode for visualizing the treatment area and supporting transducer contact | | **Display listed in the 510(k) summary** | 18.5-inch, 16:9, 1920 × 1080 | 15-inch, 4:3, 1024 × 768 | | **Console changes** | Updated industrial design, interface, hardware and operating system | Earlier console design and system components | | **Evidence of better patient outcomes** | Not established by K233996 | Not a superiority comparison | *Source: the 510(k) summary published in FDA's [K233996](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233996.pdf), especially its device description and substantial-equivalence table on PDF pages 5–8.* ### What stayed the same The 510(k) summary says PRIME and the predicate share the same intended use and US indications. It also says they use identical ultrasound signal energy and treatment guidelines, the same console-handpiece-transducer component structure, and the same imaging mode. Most directly, the 510(k) summary says the differences do not significantly affect clinical functionality or performance specifications. That wording is the most useful answer for a prospective patient. PRIME modernizes how the system is presented and operated. The 510(k) record does not describe a new treatment mechanism or a clinically superior result. It also does not compare individual practitioners, treatment plans or patient outcomes. ### What the PRIME console changes The 510(k) summary documents a larger, higher-resolution display, a modernized graphical interface, updated hardware and a newer operating system. The [manufacturer's PRIME product page](https://ultherapy.com/physicians-the-gold-standard) also describes a tiltable capacitive touchscreen, an integrated work surface, quieter system sounds and faster ultrasound-image refresh. Those are product and workflow descriptions from the manufacturer. They should not be converted into a claim of better lifting, longer-lasting results, less pain or improved safety. ### What the US FDA record means—and what it does not K233996 is a US 510(k) clearance dated February 22, 2024. FDA determined that the modified Ulthera System was substantially equivalent to its legally marketed predicate for the indications stated in the record. A 510(k) clearance is not a premarket approval, and this US record does not establish clearance, licensing or permitted advertising claims in Korea or any other jurisdiction. The performance section describes non-clinical software, usability, mechanical, electrical, packaging and ultrasound-output testing. It does not report a head-to-head patient trial of PRIME versus the earlier console. That is why the honest comparison stops at the documented system and workflow changes. For the treatment mechanism itself, see [what Ultherapy is and how MFU-V works](https://ultherapy-seoul.com/what-is-ultherapy/). ### Questions to ask before booking - Which Ulthera console will be used for my appointment? - Who will assess me, plan the treatment and operate the system? - How will the treatment area and goals be chosen for me? - How will ultrasound visualization be used during treatment? - Which benefits, limitations and possible adverse effects apply to my situation? A console name cannot answer those questions on its own. If you are considering treatment in Seoul, [Delight Dermatology Clinic’s Ultherapy consultation overview](https://hifuseoul.com/procedures/ultherapy-seoul/#procedure-process) explains the consultation process. Ask the provider to identify the console used for your appointment. ### Frequently asked questions ### Are Ultherapy PRIME and earlier Ultherapy the same treatment? They are versions of the Ulthera System. In the 510(k) summary for K233996, PRIME and the predicate console have the same intended use and indications, identical ultrasound signal energy and treatment guidelines, the same main components, and the same imaging mode. PRIME changes the console, interface and supporting hardware. ### Does Ultherapy PRIME produce better patient results? The K233996 record does not establish better patient outcomes. The 510(k) summary says the console differences do not significantly affect clinical functionality or performance specifications. The manufacturer describes workflow and visualization updates, but those descriptions should not be read as proof of superior clinical results. ### What is the US regulatory status of Ultherapy PRIME? K233996 is a US 510(k) clearance, not a premarket approval. FDA found the modified Ulthera System substantially equivalent to its legally marketed predicate for the listed US indications. The record does not establish clearance in Korea or any other country. ### How can I know which Ultherapy console a clinic uses? Ask the provider to identify the console that will be used for your appointment. ### Primary sources 1. US Food and Drug Administration. [K233996: Ulthera System (UC-1 Control Unit PRIME), decision letter and 510(k) summary](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233996.pdf). February 22, 2024. 2. Merz Aesthetics / Ultherapy. [Meet Ultherapy PRIME: official manufacturer product page for physicians](https://ultherapy.com/physicians-the-gold-standard). ## What Ultrasound Imaging Shows During Ultherapy Source: https://ultherapy-seoul.com/ultherapy-ultrasound-visualization/ Updated: 2026-10-18 Ultherapy combines ultrasound imaging with focused ultrasound treatment. In the current US instructions, the DeepSEE display shows tissue from the surface to 8 mm, while the listed treatment transducers focus at 1.5, 3.0 or 4.5 mm. The image helps the trained user check skin contact and an appropriate treatment depth. It is not documented as a test that predicts an individual's final appearance. Figure: Editorial ultrasound display showing an 8 millimeter viewing range and separate focal points at 1.5, 3.0 and 4.5 millimeters Ultrasound imaging range and treatment focal depths. The phrase "ultrasound visualization" can make the screen sound like a diagnostic scan or an outcome forecast. The public device records describe a narrower role. They say the operator may visualize the tissue in the treatment path, confirm coupling between the transducer and skin, and check the selected treatment depth. ### The imaging window and treatment depth are different The current US [Ultherapy PRIME instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list an imaging depth of 0–8 mm for each of the six transducers. The same table lists treatment focal depths of 1.5, 3.0 or 4.5 mm, depending on the transducer. The instructions also summarize the system's treatment-depth range as 1.5–4.5 mm. In other words, the 8 mm specification describes how much tissue can appear in the displayed field. It does not mean the system treats every layer from the surface to 8 mm. A treatment line creates discrete thermal coagulation points at the selected transducer's focal depth. Figure: Diagram of a tissue display from zero to 8 millimeters with separate treatment focal depths at 1.5, 3.0 and 4.5 millimeters Imaging range and treatment focal depths; not to anatomical scale. ### What the operator is checking The US instructions state that the imaging feature lets the user view skin and subdermal regions before treatment. The listed purposes are to ensure proper coupling of the transducer to the skin and to confirm an appropriate treatment depth, with avoiding bone given as an example. The instructions tell the operator to place the treatment window flush with the skin, begin imaging and review the displayed tissue before delivering a line. FDA's 2024 [K233996 summary for the PRIME console](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233996.pdf) repeats those functions. It also says PRIME and the earlier predicate use the same imaging mode. The earlier [K180623 summary](https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180623.pdf) uses the same 8 mm range and the same coupling and depth language. Those documents support a procedural-control description; they are not a head-to-head test of outcomes with and without visualization. ### What the image does not establish None of these three records validates the display as a test for predicting how much lift a person will see, whether two sides will respond identically, how long a result will last or whether one console will produce a better clinical result. Imaging can make specific steps inspectable during the procedure without turning biological response into a certainty. The labeled imaging uses are tissue visualization, skin coupling and confirmation of treatment depth. ### Four questions to ask at a consultation 1. Which system and transducer would be used for the area being considered? 2. What will the operator check on the image before delivering energy? 3. What finding would make the operator change position, depth or the plan? 4. What can the image confirm during the procedure, and what remains uncertain about my result? Ask the provider which system and transducers will be used. Imaging-guided treatment is described in [Delight Dermatology's notes on Ultherapy Prime and DeepSEE](https://hifuseoul.com/procedures/ultherapy-seoul/#procedure-devices). ### Regulatory and geographic scope The documents cited here are US manufacturer instructions and FDA 510(k) records. They do not establish Korean authorization, a provider's credentials or personal suitability for treatment. The screen is one input to a trained operator. It does not replace an examination, medical history or discussion of alternatives and adverse effects. For the broader mechanism and US regulatory history, see [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/). ### Common questions ### Does the Ultherapy screen show how deep treatment will go? The screen displays tissue from the surface to 8 mm in the current US instructions. The selected transducer determines a treatment focal depth of 1.5, 3.0 or 4.5 mm. The viewing range and treatment depth are therefore related but different specifications. ### What is DeepSEE imaging used to check? The US instructions and FDA records describe imaging for visualizing dermal and subdermal tissue, checking that the transducer is coupled to the skin, and confirming an appropriate treatment depth, including avoiding bone. ### Can the image predict my Ultherapy result? The cited device records do not validate the image as a test for predicting an individual result, symmetry or duration. They document procedural visualization functions. ### Primary sources 1. Ulthera, Inc. [Ultherapy PRIME Instructions for Use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf), especially sections 2.1, 3.1, 3.2.3 and Table 3.4. 2. US Food and Drug Administration. [K233996: Ulthera System PRIME](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233996.pdf), 510(k) summary, February 22, 2024. 3. US Food and Drug Administration. [K180623: Ulthera System](https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180623.pdf), 510(k) summary, August 23, 2018. ## Ultherapy vs Thread Lift: How They Actually Differ Source: https://ultherapy-seoul.com/ultherapy-vs-thread-lift/ Updated: 2026-10-18 Ultherapy® (MFU-V) and thread lifts both target mild-to-moderate facial laxity but work by entirely different mechanisms. MFU-V delivers focused ultrasound to trigger new collagen and elastin over 2–3 months: nothing is implanted, and the result builds gradually. Published follow-up does not establish one duration for every patient. A thread lift places absorbable suspension sutures that reposition tissue for an immediate mechanical lift. Systematic-review evidence for thread-lift durability is limited; MFU-V has a larger controlled-trial base. The two are often complementary rather than competing. Figure: Gold dotted curves converge on a glowing point between wavy ivory layers on a navy background. Patients comparing non-surgical options for a softening jawline or early jowl almost always run into both names. Because they are marketed for the same concern, it is easy to assume they are interchangeable. They are not. One is an energy-based collagen treatment; the other is a minimally invasive implant. Understanding the mechanism is the fastest way to know which fits a given face: and why a dermatologist sometimes recommends both. ### How each one works **Ultherapy (MFU-V)** delivers microfocused ultrasound to precise depths in the dermis and the superficial musculoaponeurotic system (SMAS), creating tiny thermal coagulation points. Those points trigger a wound-healing response that lays down new collagen and elastin over the following two to three months; nothing is left behind in the skin. The mechanism, depths, US FDA De Novo classification and later 510(k) clearances are covered in detail on [what Ultherapy is](https://ultherapy-seoul.com/what-is-ultherapy/), and MFU-V is regarded in the literature as the reference standard for focused-ultrasound skin lifting[5]. **A thread lift** is a different idea entirely. The clinician passes absorbable suspension sutures (commonly polydioxanone (PDO) or poly-L-lactic acid (PLLA), often barbed) under the skin and uses them to physically reposition sagging tissue. The lift is mechanical and visible immediately, and the threads also provoke some collagen formation along their path as they dissolve over months. It is a minimally invasive procedure rather than an energy treatment. ### Side-by-side at a glance | Dimension | Ultherapy (MFU-V) | Thread lift | | --- | --- | --- | | **Category** | Energy-based (focused ultrasound) | Minimally invasive suture implant | | **What is placed in the skin** | Nothing: energy only | Absorbable sutures (e.g. PDO, PLLA), often barbed | | **Immediate effect** | Subtle; the change is mostly gradual | Immediate mechanical lift | | **Peak result** | 8–12 weeks, as collagen and elastin remodel | Visible at once, then settles as swelling resolves | | **How long it lasts** | Study follow-up often reaches 180 days; duration varies individually | Variable; review evidence shows limited durability | | **Downtime** | Essentially none | Swelling and possible bruising; some social downtime | | **Most common side effects** | Transient redness and swelling; rare nerve effects | Asymmetry, swelling, bruising; uncommon extrusion or infection | | **Evidence base** | Multiple controlled studies; reference standard | Limited high-quality evidence for durability | | **Most suited to** | Mild–moderate laxity wanting gradual, natural change | Those wanting immediate repositioning of sagging tissue | ### What the evidence says about how long results last This is where the two diverge most. For MFU-V, a retrospective evaluation at 180 days found 67% of subjects with blinded-reviewer improvement and 77.7% with physician-rated improvement after a single session, with results documented through each study's follow-up rather than a universal duration[4]. For thread lifts, the picture is more cautious. A systematic review of the thread-lift literature concluded that, over the preceding decade, little substantial high-quality evidence had been added to support durable efficacy, and that most included studies showed at best a very limited durability of the lifting effect: with the two positive studies having been sponsored by thread manufacturers[1]. That does not mean thread lifts do not work; it means the immediate lift they produce tends to be shorter-lived than marketing often implies, and that candid expectation-setting matters. ### Safety profiles compared Both are far lower-risk than surgery, but the risk types differ. For MFU-V, an open-label trial across Fitzpatrick III–VI skin reported three adverse events that all resolved by day 90 without sequelae; the main transient effects are redness, mild swelling and occasional bruising[6]. For thread lifts, an evidence-based systematic review of 59 studies covering more than 14,000 patients found the most common side effects to be facial asymmetry, swelling and bruising, with serious adverse events (such as paraesthesia or injury to vessels or glands) being rare and most complications self-resolving[2]. Because a thread is a physical implant placed along a path, its uncommon problems ( visible or palpable threads, asymmetry, extrusion) are mechanical in nature, which is a different category of issue from an energy treatment. ### They are not strictly either/or In practice the two are frequently combined rather than chosen against each other. A study of suspension threads used together with MFU-V found that thread integrity was preserved and that there was greater neocollagenesis at three months when threads were combined with MFU-V than with MFU-V alone[3]. A common sequencing is to use a thread lift for an immediate repositioning effect and MFU-V for the slower, broader collagen remodeling: though whether that is appropriate depends entirely on the individual assessment. ### Which one suits you The honest framing is that neither is universally better. MFU-V suits patients with mild-to-moderate laxity who want a gradual, natural-looking change and usually same-day return to routine despite possible short-lived redness, swelling, tenderness or altered sensation; the published consensus places it in that band[7]. A thread lift suits patients who want an immediate repositioning of specific sagging tissue and accept a more variable duration and a short recovery. The full candidacy criteria ( age, laxity grade, skin quality and contraindications) are set out on the [candidates and contraindications](https://ultherapy-seoul.com/candidates-and-contraindications/) page, and if your underlying question is really MFU-V versus generic ultrasound devices, that is covered in [MFU-V vs HIFU](https://ultherapy-seoul.com/mfu-v-vs-hifu/). Thread lifts, focused ultrasound and other non-surgical options are set side by side in [an evidence review of non-surgical lifting](https://hifuseoul.com/guides/non-surgical-face-lifting-evidence/); the recovery side of an MFU-V session is detailed on the [aftercare and downtime](https://ultherapy-seoul.com/aftercare-downtime/) page. ### Risks and contraindications Redness, swelling, tenderness, bruising and altered sensation can occur. Postmarketing reports also include muscle weakness, burns, nodules and fat or volume loss; their frequency is uncertain. Discuss prior fillers and implants before treatment. In a 52-patient open-label trial across Fitzpatrick III–VI skin, the three reported adverse events resolved by day 90 without sequelae[6]. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. Thread lifting carries its own separate set of considerations, which the clinician will review if that option is on the table. ### References 1. Gülbitti HA, Colebunders B, Pirayesh A, Bertossi D, van der Lei B. Thread-Lift Sutures: Still in the Lift? A Systematic Review of the Literature. *Plast Reconstr Surg.* 2018;141(3):341e-347e. [doi:10.1097/PRS.0000000000004101](https://doi.org/10.1097/PRS.0000000000004101) · [PMID:29481392](https://pubmed.ncbi.nlm.nih.gov/29481392/) 2. Pham CT, Chu S, Foulad DP, Mesinkovska NA. Safety Profile of Thread Lifts on the Face and Neck: An Evidence-Based Systematic Review. *Dermatol Surg.* 2021;47(11):1460-1465. [doi:10.1097/DSS.0000000000003189](https://doi.org/10.1097/DSS.0000000000003189) · [PMID:34699439](https://pubmed.ncbi.nlm.nih.gov/34699439/) 3. Casabona G. Safety of Combining Facial Lifting With Suspension Threads and Microfocused Ultrasound With Visualization. *J Drugs Dermatol.* 2020;19(4):367-370. [doi:10.36849/JDD.2020.4771](https://doi.org/10.36849/JDD.2020.4771) · [PMID:32272512](https://pubmed.ncbi.nlm.nih.gov/32272512/) 4. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) 5. Vachiramon V, Pavicic T, Casabona G, et al. Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. *J Cosmet Dermatol.* 2024;24(2):e16658. [doi:10.1111/jocd.16658](https://doi.org/10.1111/jocd.16658) · [PMID:39501429](https://pubmed.ncbi.nlm.nih.gov/39501429/) 6. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/) 7. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. *Clin Cosmet Investig Dermatol.* 2015;8:47-52. [doi:10.2147/CCID.S69118](https://doi.org/10.2147/CCID.S69118) · [PMID:25709486](https://pubmed.ncbi.nlm.nih.gov/25709486/) ## What Is Ultherapy? MFU-V Technology Explained Source: https://ultherapy-seoul.com/what-is-ultherapy/ Updated: 2026-10-18 Ultherapy® (MFU-V) delivers focused ultrasound energy at three preset depths (1.5 mm (superficial dermis), 3.0 mm (mid dermis), 4.5 mm (SMAS)) creating thermal coagulation points that trigger collagen and elastin remodeling over the following months. Real-time B-mode visualization distinguishes MFU-V from generic HIFU. US FDA pathway: De Novo classification for brow lift in 2009, then 510(k) clearances for submental and lateral neck laxity in 2012 and décolletage wrinkles in 2014. Performed only by trained clinicians; not a surgical alternative for advanced laxity. Ultherapy® is a brand name for microfocused ultrasound with visualization, abbreviated MFU-V. The device sends acoustic energy from a handheld transducer into the skin and produces small, well-defined zones of thermal injury at controlled depths[1]. Those zones have two effects. The treated tissue contracts straight away, which gives a modest immediate tightening. Then a slower wound-healing response sets in, generating new collagen and, new elastin as observed in a miniature-swine study[2]. For patients comparing devices, the question that matters is rarely whether ultrasound is more powerful than radiofrequency or laser. It is what MFU-V actually delivers, and on which patients. [Candidacy assessment](https://ultherapy-seoul.com/candidates-and-contraindications/), and the [comparison with generic HIFU](https://ultherapy-seoul.com/mfu-v-vs-hifu/). Figure: Fine gold lines converge at glowing points on three curved layers against a navy background. ### How the energy is delivered An MFU-V handpiece carries interchangeable transducers, each tuned to a particular depth. The Ultherapy system as marketed in dermatology practices uses three standard depths (1.5 mm, 3.0 mm, and 4.5 mm) though not every patient is treated at every depth. A miniature-swine study observed thermal coagulation points and subsequent tissue remodeling[2]. The dermatologist selects depths for the individual anatomy and treatment area[3]. Each treatment line creates a sequence of thermal coagulation points at the selected depth. The visualization screen on the device shows the actual tissue along the transducer's path before the line is fired, which helps the clinician check skin contact and an appropriate treatment depth, including avoiding bone. This is the "V" in MFU-V and the single most important feature distinguishing it from generic HIFU devices that fire blind. The separate guide to [what the ultrasound image shows](https://ultherapy-seoul.com/ultherapy-ultrasound-visualization/) explains the documented 0–8 mm display range, selected focal depths and the limits of what the screen can establish. Figure: MFU-V focal depths: 1.5, 3.0 and 4.5 mm MFU-V focal depths: 1.5, 3.0 and 4.5 mm. Tissue depth varies by location; not to anatomical scale. ### Treatment depth specifications | Depth | Tissue layer targeted | Typical indication | | --- | --- | --- | | **1.5 mm** | Superficial dermis | Selected superficial tissue targets; anatomy determines use | | **3.0 mm** | Mid dermis | Dermal collagen network across the cheek; skin-texture tightening | | **4.5 mm** | SMAS (superficial musculoaponeurotic system) | Jawline and submental tissue: the layer surgeons mobilise during a facelift | Each transducer is engineered to deliver thermal coagulation zones at one of these depths; the clinician selects depths based on the anatomy being treated[3]. The lower-face application is detailed in [Ultherapy for the jawline and neck](https://ultherapy-seoul.com/ultherapy-jawline-and-neck/). ### US FDA regulatory pathway: what it actually covers It is common to read marketing copy that lists Ultherapy as "FDA approved" for everything from jowls to wrinkles. The accurate picture is narrower. The 2009 indication followed the De Novo pathway; the later indications followed the 510(k) pathway: For the device-generation question, see [Ultherapy PRIME vs Ultherapy](https://ultherapy-seoul.com/ultherapy-prime-vs-ultherapy/). | Year | US FDA pathway and indication | | --- | --- | | **2009** | De Novo classification: non-invasive brow lift | | **2012** | 510(k) clearance: lax submental tissue and lateral neck skin | | **2014** | 510(k) clearance: lines and wrinkles on the décolletage | These are historical US regulatory milestones. Subsequent clearances include additional body indications: [K260618](https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260618.pdf) includes skin laxity of the abdomen, anterior and posterior arms, and knees. US clearance does not determine Korean permitted uses; ask the clinician to confirm the Korean labeling for the exact device. ### What happens in the dermis after treatment In a miniature-swine model, thermal coagulation zones showed collagen remodeling and newly synthesized elastin at day 90[2]. This is preclinical evidence of tissue response. Patients should not expect to see the final result immediately. The day-of-treatment effect, beyond mild redness and a sense of warmth, is usually subtle. The change that matters builds quietly and is most apparent in photographs taken in consistent lighting around the twelve-week mark. The [aftercare and downtime page](https://ultherapy-seoul.com/aftercare-downtime/) sets out what to expect week by week. ### How long the result lasts Published studies document improvement through their defined follow-up periods, often 180 days; some small studies report selected measures to 9–12 months, but they do not establish a universal duration. Retrospective evaluation at 180 days post-treatment found that 67% of subjects showed blinded-reviewer improvement and 77.7% showed physician-rated improvement after a single MFU-V session, with no association between outcome and Fitzpatrick skin type or age[4]. Ultherapy is not a permanent treatment (no non-surgical collagen-induction modality is) and the underlying aging process continues. Maintenance timing is separate from efficacy duration and is decided after an individual reassessment. If you are weighing when in the year to book, season is not a constraint for MFU-V: the sun-exposure and timing details are in [Ultherapy in summer](https://ultherapy-seoul.com/ultherapy-in-summer/). Blinded-reviewer improvement 67% Physician-rated improvement 77.7% Evidence window 180 days No association between outcome and Fitzpatrick skin type or age[4]. Single-session outcomes at 180 days (Fabi and Goldman, 2014) ### What MFU-V is not for MFU-V is a tightening and lift technology operating in the deep dermis and SMAS. It does not treat surface concerns: pigmentation, fine surface telangiectasia, acne scarring, or wrinkles that originate in muscle movement. Those concerns have better-matched tools: pigmented laser, vascular laser, fractional resurfacing, neuromodulators. A careful dermatologist combines or sequences modalities. An Ultherapy session on its own is rarely the complete answer for someone with several skin concerns. How one clinic decides whether a session stands alone or is paired with other care is set out in [Delight Dermatology's treatment process](https://hifuseoul.com/procedures/ultherapy-seoul/#procedure-process). ### Pain and anesthesia The honest answer is that MFU-V is uncomfortable, particularly at the 4.5 mm depth over bony zones (the jawline, the lower chin). Most clinics offer one or more of: oral analgesia taken before the session, topical anesthetic applied for thirty to sixty minutes, and a short course of an anxiolytic for highly sensitive patients. Local nerve blocks are also used by some clinicians. The clinical team should discuss the option mix with you at consultation; tolerance varies more than most people expect. ### Risks and contraindications Redness, swelling, tenderness, bruising and altered sensation can occur. Postmarketing reports also include muscle weakness, burns, nodules and fat or volume loss; their frequency is uncertain. Discuss prior fillers and implants before treatment. In a 52-patient open-label trial across Fitzpatrick III–VI skin, the three reported adverse events resolved by day 90 without sequelae[5]. The [US instructions for use](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) list open wounds or lesions, severe or cystic acne, and active or metallic implants in the treatment area as contraindications. Pregnancy, breastfeeding and anticoagulant use have not been evaluated; defer treatment during pregnancy or breastfeeding and review medications with the prescriber. Do not stop prescribed medication yourself. Avoid treating directly over an existing keloid; a history of abnormal scarring requires assessment. Korean treatment must follow the labeling for the exact device used. ### References 1. Vachiramon V, Pavicic T, Casabona G, et al. Microfocused Ultrasound in Regenerative Aesthetics: A Narrative Review on Mechanisms of Action and Clinical Outcomes. *J Cosmet Dermatol.* 2024;24(2):e16658. [doi:10.1111/jocd.16658](https://doi.org/10.1111/jocd.16658) · [PMID:39501429](https://pubmed.ncbi.nlm.nih.gov/39501429/) 2. Marquardt K, Hartmann C, Wegener F, et al. Microfocused Ultrasound With Visualization Induces Remodeling of Collagen and Elastin Within the Skin. *J Cosmet Dermatol.* 2024;24(1):e16638. [doi:10.1111/jocd.16638](https://doi.org/10.1111/jocd.16638) · [PMID:39545626](https://pubmed.ncbi.nlm.nih.gov/39545626/) 3. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. *Clin Cosmet Investig Dermatol.* 2015;8:47-52. [doi:10.2147/CCID.S69118](https://doi.org/10.2147/CCID.S69118) · [PMID:25709486](https://pubmed.ncbi.nlm.nih.gov/25709486/) 4. Fabi SG, Goldman MP. Retrospective evaluation of micro-focused ultrasound for lifting and tightening the face and neck. *Dermatol Surg.* 2014;40(5):569-75. [doi:10.1111/dsu.12471](https://doi.org/10.1111/dsu.12471) · [PMID:24689931](https://pubmed.ncbi.nlm.nih.gov/24689931/) 5. Harris MO, Sundaram HA. Safety of Microfocused Ultrasound With Visualization in Patients With Fitzpatrick Skin Phototypes III to VI. *JAMA Facial Plast Surg.* 2015;17(5):355-7. [doi:10.1001/jamafacial.2015.0990](https://doi.org/10.1001/jamafacial.2015.0990) · [PMID:26313402](https://pubmed.ncbi.nlm.nih.gov/26313402/)