Ultherapy (a focused ultrasound device) is approved by Korea’s Ministry of Food and Drug Safety (MFDS) as a focused ultrasound stimulation system, approval no. 수허09-1024호 (수허 = import). The approved intended use is lifting of the eyebrows, a lax jawline and the upper chest, plus improving wrinkles of the upper chest. The cheeks and neck are not in the intended use. [as of September 2026]
Common questions
How much does sagging skin lift?
In two studies that measured eyebrow height, the lift was less than 2 mm. One study reported an average of 1.7 mm 90 days after treatment, and the other (25 people in Taiwan) reported 0.47 mm after 90 days. Neither study summary names the device brand.
In a study that treated the lower face of 103 people and assessed 93 of them after 90 days, raters who did not know the treatment details judged from photos that sagging had improved in 58.1%. We did not find a trial that compared the device with a fake treatment. See the studies
When do results show, and how long do they last? When is the next session?
Most studies measured results 90 days after treatment, and few followed people for longer. In the Taiwan study of 25 people, eyebrows that had risen at 90 days were 0.12 mm lower than before treatment at 180 days.
In a study of 20 people whose summary does not name the device brand, 6 of the 14 people who could be assessed were judged improved on photos after 1 year.
The approval documents and studies we checked for this article do not say when to repeat treatment. See details
How is it different from Thermage?
The energy and the approved intended use are different. Ultherapy is approved for lifting the eyebrows, a lax jawline and the upper chest with focused ultrasound. Thermage FLX (a radiofrequency device) is approved for treating wrinkles around the eyes and on the face with radiofrequency current.
We did not find a trial that named both devices by brand and compared them directly. A table that sets the two approval records side by side, and the comparison studies, are in a separate article. See how Ultherapy and Thermage differ (in Korean) · See the source text
How many shots are needed, 300 or 600? How much does it cost?
The approval documents and studies we checked for this article do not say how many shots to get. The directions for use in the approval documents describe treatment in lines, and the unit “shot” (one pulse of ultrasound) does not appear in the parts we read.
We have not published prices yet (and have no prices by number of shots either). A range will appear here once we have 3 or more public prices for the same conditions on file. When you compare quotes, check that the product name, the amount and the number of sessions are the same. See why
Does it hurt enough to need sedation?
In studies, pain during treatment was 4.85 to 6.53 out of 10, and the lowest value is the average of 785 people in an analysis that Merz paid for.
In a Hong Kong study of 49 people treated without local anesthetic (no device brand in the study summary), pain was recorded as severe in 54.4% of treatments. The precautions for use in the approval documents say nothing about anesthesia, and none of the studies we looked at for this article dealt with sedation.
The approval documents say that redness and swelling can appear right after treatment, and that mild bruising is rare. See details
Are there side effects such as hollow cheeks or nerve damage? Can they be avoided?
The list of post-market adverse events in the approval documents includes “fat/volume loss” and “skin laxity/sagging, asymmetry”, and the same list includes paralysis, muscle weakness and nerve problems that lasted for months.
The same documents state that these were voluntary reports, so how often they occur is hard to estimate. We did not find a study that measured how often they occur.
The approval documents do not say separately how to avoid these events. The directions for use say to leave 2 to 3 mm between lines, and warn that overlapping lines without spacing can overheat tissue and cause side effects. See details
Does it also help nasolabial folds or a double chin?
Nasolabial folds (the lines from the nose to the corners of the mouth) are not in the approved intended use, and neither are the cheeks or neck. The only facial areas in the intended use are the eyebrows and a lax jawline.
Under the chin, the Taiwan study of 25 people (no device brand in the study summary) found a clear change after 90 days, but no difference from before treatment after 180 days. None of the studies we looked at for this article measured nasolabial folds. See the source text · See the studies
How is it different from other focused ultrasound devices?
The approved intended use differs from one approval number to the next. Of 48 valid focused ultrasound records in Korea, 43 list eyebrow lifting as the only facial area, and Ultherapy is among the 5 that list facial areas beyond the eyebrows.
Among those, 제허14-1422호 (model name SHURINK) lists, by cartridge, firmness improvement of both cheeks and improvement of wrinkles around the eyes, around the mouth and on the neck, in addition to eyebrow lifting. We did not find a study that named Ultherapy and another focused ultrasound device by brand and compared them directly. See details
What to ask at your consultation
The items below are based on the approval documents. If any of them apply to you, tell the medical staff before treatment.
- Which device is it, and what is its approval number? Focused ultrasound devices have a different intended use for each approval number, and some records split the intended use by cartridge.
- Do you have a pacemaker, a defibrillator or a mechanical implant? The approval documents list these as contraindications.
- Do you have a wound, a lesion, or severe or cystic acne in the treatment area? The approval documents list these as contraindications.
- Have you had filler in your face, or do you have keloids? According to the approval documents, use directly over filler areas or keloids is not recommended.
- Are you taking any drugs? Tell the medical staff about every drug you take. According to the approval documents, patients who plan anticoagulant treatment were not evaluated.
- Are you pregnant or breastfeeding, or do you have diabetes, an autoimmune disease, epilepsy, herpes simplex, facial nerve palsy or a bleeding disorder? According to the approval documents, these patient groups were not evaluated.
- Will the area around the eyes be treated? The approval documents recommend avoiding the eyes, the eyelids and the area inside the orbital rim, and warn against use in any position where the ultrasound could reach the eye.
Contact the clinic if something is wrong with your eyes after treatment
The approval documents warn against using the device in any position or way that lets the ultrasound reach the eye. If your vision becomes unclear or something seems wrong with your sight after treatment, contact the clinic that treated you and have a doctor assess you. A case report on high-intensity ultrasound of the eyelid, whose summary does not name the device brand, described one person who still had eye damage 6 months after treatment. See details
Evidence and details
What the approval record says
Ultherapy is approved as a Class 3 medical device (in Korea’s four-class system), and the record is in the MFDS medical device database (의료기기안심책방).
| Item | Approval record text |
|---|---|
| Approval no. | 수허09-1024호 |
| Company | Merz Asia Pacific Pte. Ltd. (멀츠아시아퍼시픽피티이엘티디) |
| Product name | Ulthera system, Ulthera Prime, Ultherapy Prime |
| Item name (classification no.) | Focused ultrasound stimulation system (A35100.03) |
| Class · approval date | Class 3 · 2009-10-13 |
| Intended use | “Used to coagulate tissue with focused ultrasound to lift the eyebrows, a lax jawline and the upper chest, and to improve wrinkles of the upper chest (Decollete)” |
| Remarks | [√] technical document review [ ] clinical data review |
| Checked | 2026-09-22 |
In the remarks field of the record, “technical document review” is marked and “clinical data review” is blank.
The intended use of 수허09-1024호, checked on September 22, 2026, does not include the cheeks or neck, and does not include nasolabial folds. The facial areas in the intended use are the eyebrows and a lax jawline, and wrinkle improvement is listed only for the upper chest. The precautions for use in the same approval also report side effects separately for the clinical evaluation of eyebrow and lax jawline treatment and for the clinical evaluation of upper chest treatment.
Thermage FLX (수허18-245호) is approved separately, as a general electrosurgical device that coagulates tissue with radiofrequency current to treat wrinkles around the eyes and on the face non-invasively. We did not find a trial that named both devices by brand and compared them directly. A table that sets the two approval records side by side, and the comparison studies, are in How Ultherapy and Thermage differ (in Korean).
How the effect is explained
According to the approval record, Ultherapy coagulates tissue with focused ultrasound. The performance document gives a treatment depth of 1.5 to 4.5 mm and a temperature around the focal point of 44°C or higher. According to the directions for use, there are six transducers that are placed on the skin, with focal depths of 1.5 mm, 3.0 mm and 4.5 mm.
The same directions describe treatment in lines. After one line is treated, the directions say to move the transducer 2 to 3 mm and treat the next line, and they warn that overlapping lines without proper spacing can overheat tissue and cause side effects. The sentences from the precautions for use and the directions for use that we quoted for this article do not use the unit “shot,” and none of them sets how many shots to get. The figures on pages 5 and 6 of the directions for use, which show the recommended number of lines by area, are images and we could not read them.
When the effect starts and how long it lasts
Most studies measured results 90 days after treatment. A review that gathered 16 studies stated that every included study was done in women and that there were no follow-up data over a longer period. The patient-related sentences we took from the Ultherapy precautions for use and directions for use do not say when to repeat treatment, and none of the studies we looked at for this article set or compared a time to repeat treatment.
The Taiwan study of 25 people (2 men) measured the face with three-dimensional imaging. Eyebrows rose by an average of 0.47 mm after 90 days but were 0.12 mm lower than before treatment after 180 days. The change under the chin was also clear after 90 days, with no difference from before treatment after 180 days. The device is described as microfocused ultrasound with visualization (MFU-V), and the study summary does not name a brand.
The 20-person 1-year study followed 20 people for 1 year with no comparison group. On an overall improvement scale, the study reported that 95% had improved after 1 year. Raters who did not know the treatment details judged from photos that 6 of the 14 people who could be assessed had improved.
In a study of 22 women, people who had one Ultherapy session had lower skin elasticity readings at 4 weeks than before treatment, and higher readings than before treatment at 12 and 24 weeks. Two of the researchers were Merz employees, and one other received research support from Merz.
What the studies reported
Most studies that treated the face with Ultherapy or an ultrasound device of the same type compared people before and after treatment with no comparison group, and we did not find a trial that compared the device with a fake treatment. The studies measured eyebrow height and sagging of the lower face and under the chin, and none measured nasolabial folds. On September 15 and 22, 2026, we searched PubMed for microfocused ultrasound and Ultherapy combined with lifting or sagging, sham (a fake treatment), and Korean.
| Study | Participants | Device | Reported result | Funding and interests |
|---|---|---|---|---|
| US study of 36 people | 36 enrolled, 35 assessed | No brand in the study summary (an investigational focused ultrasound device) | After 90 days, 3 raters judged eyebrow lift in 30 people; average eyebrow height change 1.7 mm | No sponsor named in the PubMed record |
| US study of 93 people | 103 enrolled, 93 assessed | Ulthera System | After 90 days, sagging improved in 58.1% on photo assessment, 63.6% on measured assessment | No sponsor named in the PubMed record |
| Taiwan study of 25 people | 25 people | MFU-V, no brand in the study summary | Eyebrows up 0.47 mm after 90 days, 0.12 mm lower than before treatment after 180 days | Not stated in the PubMed record |
| 20-person 1-year study | 20 people | MFU-V, no brand in the study summary | After 1 year, 6 of 14 improved on photo assessment | Not stated in the PubMed record |
| Trial in 20 Chinese women | 20 women, one side of the face treated | A new device with no brand in the study summary | After 3 months, tightening judged in 14 people; lower face volume down 0.29 mL vs. up 0.42 mL on the untreated side | National Natural Science Foundation of China and others |
| Analysis that pooled 42 studies | 42 studies | MFU-V | Overall improvement rated by investigators 89% (411 people), patient satisfaction 84%, 62% when a “neutral” option was offered | Funded by Merz North America; 7 researchers consult or speak for Merz |
The US study of 36 people treated the face and neck of 36 people and assessed 35 of them. After 90 days, 3 raters who did not know the treatment details judged that the eyebrows had clearly risen in 30 of the 35 (86%). The eyebrow height change measured on photos averaged 1.7 mm, and the study summary does not give the number of people in this measurement. Follow-up lasted 90 days, and the study summary describes the device as “an investigational focused ultrasound device” instead of naming a brand.
The US study of 93 people treated the lower face of 103 people with the Ulthera System and assessed 93 of them after 90 days. Raters who viewed three-dimensional photos without knowing the treatment details found that skin sagging had improved in 58.1%, and measured improvement was 63.6%.
The trial that compared a treated side with an untreated side was the trial in 20 Chinese women. The researchers treated one side of the face, compared it with the other side, and reported clear tightening in 14 people after 3 months. The device in this study was not Ultherapy but a new device whose brand the study summary does not give.
The analysis that pooled 42 studies reported overall improvement rated by investigators of 89% (411 people). Patient satisfaction was 84%, but 62% when only surveys with a “neutral” option were counted, and the research team stated that the effect may have been inflated because neutral answers were classed as positive. The team also wrote that many of the included studies had no comparison group or did not decide in advance who would get which treatment, and did not hide the treatment details from raters. Merz North America funded this analysis, and 7 of the researchers receive consulting and speaking support from Merz. The company that holds the Korean approval for Ultherapy is Merz Asia Pacific.
When the effect was smaller
In the US study of 93 people, the share with no change was 54.5% among those with a body mass index (BMI) over 30 and 12.2% among those with a BMI of 30 or under, and the research team wrote that results were better at a BMI of 30 or under. According to the analysis that pooled 42 studies, 2 of the included studies reported the effect of BMI.
How the approval wording differs for other focused ultrasound devices
Of 1,139 records in 11 item classifications for ultrasonic surgical devices and electrosurgical devices (as of September 22, 2026), 211 have words such as lifting, wrinkles or firmness in the intended use. Of those, 48 are ultrasound records that are valid and not for export only, and in 43 of them eyebrow lifting is the only facial area in the intended use. The records that list facial areas beyond the eyebrows are the 5 in the table below, including Ultherapy.
| Approval no. (company) | Product or model name | Facial part of the intended use (record text) | Remarks | Checked |
|---|---|---|---|---|
| 수허09-1024호 (Merz Asia Pacific Pte. Ltd., 멀츠아시아퍼시픽피티이엘티디) | Ulthera system and others | “eyebrows, lax jawline … lifting” | Technical document review | 2026-09-22 |
| 제허14-1422호 (Classys Inc., (주)클래시스) | Model name SHURINK | “eyebrow lifting … face (both cheeks) … firmness improvement … improvement of wrinkles around the eyes, wrinkles around the mouth, neck wrinkles” | Technical document review | 2026-09-22 |
| 제허21-831호 (Classys Inc., (주)클래시스) | Model name SHURINK UNIVERSE | “eyebrow lifting … improvement of wrinkles around the eyes wrinkles around the mouth neck wrinkles” | Technical document review | 2026-09-22 |
| 제허17-256호 (Classys Inc., (주)클래시스) | Model name Ulfit | “eyebrow lifting … face (both cheeks) … firmness improvement of the skin and subcutaneous tissue” | Blank | 2026-09-22 |
| 수허21-183호 ((주)신한씨스텍) | Sofwave System | “improves wrinkles of both cheeks, chin, eyebrows, neck (this product must be used on wrinkle patients aged 22 or older)” | Technical document review | 2026-09-22 |
제허14-1422호 (model name SHURINK) and 제허21-831호 list the cartridge models that can be used for each intended use. In 제허14-1422호, eyebrow lifting, firmness improvement of both cheeks, and improvement of wrinkles around the eyes, around the mouth and on the neck are listed under different cartridge models. 제허26-208호 from the same company has only one intended use, “a device used to coagulate tissue for eyebrow lifting.”
Of the 211 records, the 1 record with “clinical data review” marked in the remarks field is a radiofrequency device (수허23-392호). The ultrasound records in the table above have only “technical document review” marked, or have blank remarks.
A comparison trial in 20 Koreans treated the two sides of the face with two different focused ultrasound devices. The trial reported similar results on assessment by raters who did not know the treatment details and on measured assessment, and differences in satisfaction and pain. The study summary does not name the brand of either device. We did not find a study that named Ultherapy and another focused ultrasound device by brand and compared them directly.
What side effects have been reported
According to the Ultherapy precautions for use, the side effects reported in the clinical evaluation of eyebrow and lax jawline treatment were “mild and transient.” Redness (erythema), swelling and welting (local raised swelling) can appear right after treatment. Brief discomfort can occur while energy is delivered, and discomfort or tenderness to the touch can occur after treatment. The document states that mild bruising from injury to blood vessels in soft tissue is rare.
According to the same document, inflammation of motor nerves can cause temporary local muscle weakness after treatment, and inflammation of sensory nerves can cause temporary numbness. No permanent damage to the facial nerve was reported during the clinical trials. Improper technique (for example, a tilted transducer, wrong line spacing or a gel pocket) can cause burns and can leave permanent scars. The document states that there were no serious adverse reactions during the clinical trials.
According to the same document, the post-market adverse events were identified from routine use after what the document calls “FDA approval” and from the clinical literature on focused ultrasound devices. The skin and soft tissue category includes burns or blisters, nodules, “fat/volume loss,” “skin laxity/sagging, asymmetry,” pigment changes and scars. The nerve category includes numbness and abnormal sensation, paralysis and partial paralysis (muscle weakness), speech problems and vision changes. The document states that these events were reported voluntarily from a population of unknown size, so it is not always possible to estimate their frequency reliably or to establish that Ultherapy caused them, and it notes that some nerve problems lasted for months. The precautions for use do not say separately how to avoid the events on this list. The warnings about treatment technique are the burn item above, the line spacing warning in the directions for use, and the gel warning that “improper contact can cause side effects.”
The warnings in the precautions for use say that Ultherapy must not be used on a patient’s eyes, or on the eyelids or inside the orbital rim in any position or technique that lets ultrasound energy reach the eye. A case report described one person who, 6 months after a single cosmetic high-intensity ultrasound treatment of the eyelid, still had corneal clouding, iris atrophy and a cataract at the edge of the lens; the person’s vision was 20/20. The study summary does not name the device brand.
If your vision becomes unclear or something seems wrong with your sight after treatment, contact the clinic that treated you and have a doctor assess you.
A series of 5 cases described 5 people who developed blisters, erosions or ulcers, tissue atrophy after swelling, and skin necrosis after one Ultherapy treatment, and the research team wrote that serious adverse reactions can occur and may be underreported. Case reports describe what happened to one or a few people, so they do not show how often something occurs.
A review that gathered 106 “Ulthera” reports from the US FDA medical device adverse event database (MAUDE) stated that fat atrophy, nerve after-effects (including nerve damage, local numbness, abnormal sensation and drooping eyelids) and scarring were the most often reported. The research team regarded these data as “anecdotal and largely unverified.” We did not find a study that measured how often fat atrophy or nerve damage occurs with a known total number of patients.
A study that looked back at the records of 39 people who had focused ultrasound treatment reported complications in 23%, including temporary paralysis of the lips or eyebrows and changes that looked like fat atrophy. Of the 39 people, 38 had fractional CO2 laser treatment on the neck during the same period.
Pain was 5.68 to 6.53 out of 10 depending on the area in the US study of 93 people, and the pooled average for 785 people was 4.85 in the analysis that pooled 42 studies (funded by Merz). The Hong Kong study of 49 people, which gave 68 treatments to 49 Chinese people without local anesthetic, recorded severe pain in 54.4% of treatments and local bruising in up to 25% of treatments, and reported no serious permanent side effects up to 6 months. The summary of this study does not name the device brand. The Ultherapy precautions for use give no guidance on anesthesia, and none of the studies we looked at for this article dealt with sedation.
What the documents say to be careful about after treatment
The Ultherapy precautions for use and directions for use contain no patient care instructions for after treatment, such as cold compresses or sun protection. The cleaning and care section of the directions for use explains how to clean the transducer. Instructions can differ by product and procedure. Check the actual instructions with the medical staff who treated you.
We have not published prices yet
We publish a price range only after we have collected 3 or more public prices under the same conditions. For Ultherapy the count is still 0. When you look at quotes, check that the product name, the amount and the number of sessions are the same, so that you are comparing the same conditions.
What we have not confirmed yet
- We have not collected a single public price for Ultherapy under the same conditions. The same goes for prices by number of shots.
- The Ultherapy attached documents are marked as not public, but they opened in the site’s document viewer, and we could not confirm how their public status is decided. The documents contain no date, so we could not confirm when they were last revised either.
- The figures on pages 5 and 6 of the Ultherapy directions for use, which show the recommended number of lines by area, are images and we could not read them.
- The number of people and the duration of the “clinical evaluation” and the “clinical trials” mentioned in the precautions for use are not in the document, so we could not confirm them.
- We did not look up the MFDS explanation of what the “technical document review” and “clinical data review” marks in the approval record mean.
- We did not open the attached documents (contraindications and side effects) for the 4 other ultrasound devices in the table above.
- We did not look at records outside the 11 item classifications (for example, combined medical stimulators), or at intended uses that do not contain words such as lifting, wrinkles or firmness.
- We could not confirm the device brand and funding of the US study of 36 people, the Taiwan study of 25 people, the 20-person 1-year study and the Hong Kong study of 49 people, or the device brand in the study that looked back at 39 people’s records and in the eyelid case report. The study summary of the US study of 36 people does not give the number of people in whom the 1.7 mm eyebrow height was measured, and the table in the review that gathered 16 studies gives it as 30.
- We did not find a trial that compared the device with a fake treatment, or a comparison trial that followed people for longer than 1 year. We also did not find a study that compared times to repeat treatment or methods of anesthesia.
Related pages
- Thermage (in Korean)
- How Ultherapy and Thermage differ (in Korean)
- Skincare routine guide after a procedure (in Korean)
- Guide to types of skin procedures (in Korean)
Sources
- Korea’s Ministry of Food and Drug Safety (식품의약품안전처), MFDS medical device database (의료기기안심책방). 멀츠아시아퍼시픽피티이엘티디 (Merz Asia Pacific Pte. Ltd.) 수허09-1024호 Ulthera system. Approval record and attached documents (사용시주의사항 · 사용방법 · 성능) [precautions for use, directions for use, performance]. Checked 2026-09-22. Korean originals of quoted text: 사용목적 “집속된 초음파로 조직을 응고하여 눈썹, 늘어진 턱선, 가슴윗부분을 리프팅하고 가슴윗부분(Decollete)의 주름(wrinkles)을 개선하는데 사용”; 비고 “기술문서 심사”, “임상자료 심사”; 사용시주의사항 “경미하며 일시적”, “FDA 승인”, “지방/제척 감소” (as printed in the document; 제척 is not a standard word and is read here as 체적, volume), “피부 늘어짐/처짐, 비대칭”; 사용방법 “잘못된 접촉은 부작용을 발생시킬 수 있다”
- Korea’s Ministry of Food and Drug Safety (식품의약품안전처), MFDS medical device database (의료기기안심책방). 솔타메디칼코리아 유한회사 (Solta Medical Korea) 수허18-245호 Thermage FLX System. Intended use in the approval record. Checked 2026-09-22
- Korea’s Ministry of Food and Drug Safety (식품의약품안전처), MFDS medical device database (의료기기안심책방). Lists and detail pages for item classifications A35100.03 · A35100.02 · A35100.01 · A35100 · A35010.01 · A35010 · A35010.02 · A35020.01 · A35020 · A35030.01 · A35040.01, intended use, remarks and status of 1,139 records. Checked 2026-09-22
- Korea’s Ministry of Food and Drug Safety (식품의약품안전처), MFDS medical device database (의료기기안심책방). (주)클래시스 (Classys Inc.) 제허14-1422호 · 제허21-831호 · 제허17-256호 · 제허26-208호, (주)신한씨스텍 수허21-183호 Sofwave System, 비티엘메디컬테크놀로지코리아(유) (BTL Medical Technologies Korea) 수허23-392호. Intended use and remarks on the detail pages. Checked 2026-09-22. Korean originals of quoted text: Ulthera system “눈썹, 늘어진 턱선 … 리프팅”; SHURINK “눈썹리프팅 … 얼굴(양볼) … 의 탄력개선 … 눈가 주름, 입가 주름, 목 주름 개선”; SHURINK UNIVERSE “눈썹 리프팅 … 눈가 주름 입가 주름 목 주름 개선”; Ulfit “눈썹리프팅 … 얼굴(양볼) … 의 피부와 피하조직의 탄력개선”; Sofwave System “양볼, 턱, 눈썹, 목 주름을 개선 (본 제품은 만22세 이상의 주름 환자에게 사용해야 함)”; the same company’s eyebrow-only record quoted in the text “조직을 응고하여 눈썹 리프팅에 사용하는 기기”
- Contini M, Hollander MHJ, Vissink A, et al. A Systematic Review of the Efficacy of Microfocused Ultrasound for Facial Skin Tightening. Int J Environ Res Public Health. 2023;20(2):1522. PMID 36674277 · full text checked · authors declared no conflicts of interest · the review that gathered 16 studies in the text
- Lu PH, Yang CH, Chang YC. Quantitative Analysis of Face and Neck Skin Tightening by Microfocused Ultrasound With Visualization in Asians. Dermatol Surg. 2017;43(11):1332-1338. PMID 28945618 · abstract only · funding not stated in the PubMed record · the Taiwan study of 25 people in the text
- 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 · abstract only · funding not stated in the PubMed record · the 20-person 1-year study in the text
- Kerscher M, Nurrisyanti AT, Eiben-Nielson C, et al. Skin physiology and safety of microfocused ultrasound with visualization for improving skin laxity. Clin Cosmet Investig Dermatol. 2019;12:71-79. PMID 30666145 · abstract only · 2 authors Merz employees, 1 received Merz research support (PubMed conflict of interest statement) · the study of 22 women in the text
- 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. PMID 20115948 · abstract only · no sponsor named in the record · the US study of 36 people in the text
- Oni G, Hoxworth R, Teotia S, et al. Evaluation of a microfocused ultrasound system for improving skin laxity and tightening in the lower face. Aesthet Surg J. 2014;34(7):1099-110. PMID 24990884 · abstract only · no sponsor named in the record · the US study of 93 people in the text
- Zhu J, Han Y, Liu Y, et al. Evaluation of a Novel Microfocused Ultrasound with Three-Dimensional Digital Imaging for Facial Tightening: A Prospective, Randomized, Controlled Trial. Dermatol Ther (Heidelb). 2024;14(1):233-249. PMID 38100073 · abstract only · National Natural Science Foundation of China and others · a device other than Ultherapy · the trial in 20 Chinese women in the text
- 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. PMID 39540440 · full text checked · funded by Merz North America, 7 authors consult or speak for Merz · the analysis that pooled 42 studies in the text
- Jung HJ, Min J, Seo HM, et al. Comparison of effect between high intense focused ultrasound devices for facial tightening: Evaluator-blinded, split-face study. J Cosmet Laser Ther. 2016;18(5):252-6. PMID 26985696 · abstract only · funding not stated in the PubMed record · the comparison trial in 20 Koreans in the text
- Marafon SB, Marinho DR, Kwitko S. Cornea opacity, uveitis with iris atrophy and lens damage following cosmetic high-intensity ultrasound of the eyelid: a case report. BMC Ophthalmol. 2023;23(1):230. PMID 37217891 · abstract only · authors declared no conflicts of interest · the eyelid case report in the text
- Friedmann DP, Bourgeois GP, Chan HHL, et al. Complications from microfocused transcutaneous ultrasound: Case series and review of the literature. Lasers Surg Med. 2018;50(1):13-19. PMID 29154457 · abstract only · the series of 5 cases in the text
- Humphrey VS, Rambhia PH, Gmyrek R, et al. Microfocused Ultrasound With Visualization: A Systematic Review of Adverse Events and Risk of Subsequent Facelift Compromise. Dermatol Surg. 2025;51(4):424-429. PMID 39625163 · abstract only · funding not stated in the PubMed record · the review of 106 FDA reports in the text
- Sabet-Peyman EJ, Woodward JA. Complications using intense ultrasound therapy to treat deep dermal facial skin and subcutaneous tissues. Dermatol Surg. 2014;40(10):1108-12. PMID 25207762 · abstract only · the study that looked back at 39 people’s records in the text
- Chan NP, Shek SY, Yu CS, et al. Safety study of transcutaneous focused ultrasound for non-invasive skin tightening in Asians. Lasers Surg Med. 2011;43(5):366-75. PMID 21674541 · abstract only · funding not stated in the PubMed record · the Hong Kong study of 49 people in the text
Written by SKINMODU 2026-09-22 · Approval records checked 2026-09-22 · Studies checked 2026-09-22 · 2 cross-reviews 2026-09-22 (Codex · Gemini) · Final edit by Fable · No prices collected yet · Rebuilt in the new layout 2026-09-27 · English edition 2026-10-04, translated from the Korean page as of 2026-09-27