Seoul
Chief MD, Gangnam
Duk-ha Kim
The trust our patients have placed in this clinic was built on conviction and principle. We intend to hold to both, unchanged, through the next hundred years.
Micro-focused ultrasound (MFU-V) treatment guide
Ultherapy PRIME
Ultherapy PRIME is the control unit Merz Aesthetics launched on 23 September 2024, holding its own U.S. 510(k) record (K233996). It delivers micro-focused ultrasound while the operator views tissue layers in real time; transducers are listed at 1.5 mm, 3.0 mm and 4.5 mm, and registration is decided country by country.
- Energy
- Micro-focused ultrasound with visualization (MFU-V)
- U.S. 510(k)
- K233996 — Ulthera System (UC-1 Control Unit PRIME), decided 22 Feb 2024
- Transducer depths
- 1.5 mm / 3.0 mm / 4.5 mm
- Platform launch
- Merz Aesthetics, 23 September 2024
Is Ultherapy PRIME a separate device or a new name for the same machine?
PRIME is a separate hardware generation with its own U.S. device record, not a renamed version of the earlier unit. The FDA 510(k) database lists K233996 for the Ulthera System (UC-1 Control Unit PRIME), applicant Ulthera Inc., decided substantially equivalent on 22 February 2024 under product code OHV and 21 CFR 878.4590, and Merz Aesthetics announced the platform launch on 23 September 2024. What the manufacturer describes as changed is hardware and interface — treatments described as 20% faster, and a 35% larger screen with a faster image refresh rate — which are specification comparisons between machines and say nothing about how a treatment turns out.
Sources: FDA 510(k) K233996 — Ulthera System (UC-1 Control Unit PRIME)Merz Aesthetics — Ultherapy PRIME launch (2024-09-23)
How does micro-focused ultrasound with visualization work?
MFU-V concentrates ultrasound energy at a set depth below the skin surface while the operator looks at the tissue layers on screen before energy is delivered. The official physician material describes this real-time visualization as part of how the system is used, and the Merz Korea product page names the imaging function DeepSEE. Visualization is about where energy is placed, not a claim about how much change any individual will see.
Sources: Ultherapy official — physicians, body indicationMerz Korea — Ultherapy PRIME
Which transducer depths are used, and why does that change a quote?
Merz Korea lists transducers at 1.5 mm, 3.0 mm and 4.5 mm, and Merz Aesthetics Taiwan describes the 4.5 mm transducer as reaching the SMAS layer. Depth is chosen per area, so two quotes naming the same brand can plan different depths and different numbers of lines. That is why the transducer and the line count belong in the written quote rather than the brand name alone.
Sources: Merz Korea — Ultherapy PRIMEMerz Aesthetics Taiwan — PRIME
Which areas does the official indication wording cover?
The official wording states that the ULTHERA System is U.S. FDA-cleared to lift the eyebrow, the skin on the neck and under the chin, to improve lines and wrinkles on the décolleté, and to improve the appearance of skin laxity on the abdomen, anterior arms, posterior arms and knees. The body areas arrived through a later, separate clearance — K243035, decided substantially equivalent on 24 February 2025 — so a face plan and a body plan are different quotes even on the same machine. This wording is the U.S. record and is not a statement about what any other country permits.
Sources: Ultherapy official — physicians, body indicationFDA 510(k) K243035 — Ulthera System (arms/abdomen)
Which registration applies to the unit you are treated on?
Registration is decided country by country, so the answer depends on where you are treated and on which unit stands in the room. The records verifiable here are the U.S. clearances K233996 and K243035, a Taiwan registration listed by Merz Aesthetics Taiwan as 衛部醫器輸字第025344號, and a Merz Korea product page that lists the device under a focused-ultrasound stimulation system product category without publishing an approval number. The sources used on this page do not cover Japan or other markets. Ask the clinic to show the control unit model and to name the national registration that applies to it.
Sources: FDA 510(k) K233996 — Ulthera System (UC-1 Control Unit PRIME)FDA 510(k) K243035 — Ulthera System (arms/abdomen)Merz Aesthetics Taiwan — PRIMEMerz Korea — Ultherapy PRIME
What does the pooled evidence show, and where does it stop?
A 2024 systematic review and meta-analysis in the Aesthetic Surgery Journal pooled 42 MFU-V studies and reported investigator-assessed improvement in 89% of cases (95% CI 81–94), patient-reported improvement in 84%, and a mean pain score of 4.85 out of 10. The same review sets the limits: only 2 of the 42 studies were controlled trials, 9 were observational and 31 were pre/post designs; follow-up ran from immediately after treatment to about 365 days, with roughly 80% of it inside six months; and the authors list absent control groups, measurement bias and confounding, heterogeneity reaching I² = 97%, and publication bias. Read the 89% as a summary of mostly uncontrolled before-and-after observation over months, not as an individual outcome.
Sources: MFU-V systematic review & meta-analysis, Aesthetic Surgery Journal 2024
What did the randomized trial actually compare?
It compared two treatment techniques against each other, not treatment against no treatment. The 2021 study in Lasers in Surgery and Medicine randomised 30 people with upper-arm skin laxity in a single-blind, split-body design, treating one side with a single-plane protocol and the other with a dual-plane protocol, with follow-up at 1, 3 and 6 months. There was no untreated control group, the area studied was the arms rather than the face, and observation ended at six months.
How long does the effect last?
The pooled evidence answers a different question than duration. The 2024 meta-analysis follows treated skin from immediately after the session to about 365 days, but roughly 80% of that observation window sits inside six months, and only 2 of the 42 pooled studies used a control group — the rest are observational or pre/post, so a change recorded months out cannot be separated from what might have happened without treatment. The one randomised trial cited here compared two injection techniques against each other over six months, not treatment against no treatment, and it studied the arms rather than the face. Neither source states how long a result holds. What is more likely to decide that for an individual is the transducer depth and number of lines actually delivered and each person’s own tissue response, which is why those belong in the written plan rather than assumed from the brand name.
Sources: MFU-V systematic review & meta-analysis, Aesthetic Surgery Journal 2024Lasers Surg Med 2021 — split-body RCT, upper arms
What does a session involve, and what was recorded about discomfort?
A session runs area by area: the operator maps the region, checks the tissue layers on screen, then delivers energy in lines at the chosen depths. The pooled review reports a mean pain score of 4.85 out of 10 across studies that used different settings, areas and protocols, so that figure describes the literature rather than a fixed level for one appointment. Ask what pain management the clinic offers and what they expect in the days afterwards.
Sources: MFU-V systematic review & meta-analysis, Aesthetic Surgery Journal 2024Ultherapy official — physicians, body indication
What should you confirm and disclose before booking?
Confirm five things in writing: the control unit model, the transducer depths planned, the number of lines per area, which areas are included, and who performs the treatment. Disclose pregnancy or breastfeeding, active skin infection or open or inflamed skin in the treatment area, implants or devices in or near that area, medicines affecting bleeding or healing, and any recent fillers, toxins, lasers or other energy treatments, so the clinician can judge timing. The sources on this page do not publish a contraindication list, so treat these as disclosure topics for an in-person assessment. Contact the clinic promptly if symptoms worsen instead of settling — increasing pain, blistering, spreading redness or warmth, fever, persistent numbness, new weakness or facial asymmetry.
PRIME, an earlier Ultherapy unit, or an unnamed “HIFU”: what is in the quote?
Two quotes only become comparable once they name the same machine and the same plan. Compare the control unit, the transducer depths, the number of lines per area and the areas included — a brand name or a category word does not describe the treatment you would receive.
| What the quote says | What it refers to | What the sources on this page confirm | Confirm before comparing quotes |
|---|---|---|---|
| Ultherapy PRIME | The control unit launched by Merz Aesthetics on 23 September 2024 | Its own U.S. 510(k), K233996, for the Ulthera System (UC-1 Control Unit PRIME), decided 22 February 2024 | That the unit in the room is the PRIME control unit, plus transducer depths, lines per area and the areas included |
| An earlier Ultherapy unit | The same brand family running on previous hardware | The U.S. indication wording quoted at the PRIME launch is the existing wording; the stated differences are machine specifications such as speed and screen size | Which control unit the clinic will actually use, and whether the line count differs from a PRIME quote |
| “HIFU” with no device name | A category word for focused-ultrasound devices, not a brand or a model | Nothing — this page holds no data comparing devices across brands | The manufacturer and model name in writing, because a category word does not identify the machine |
This table is a consultation map for making quotes comparable. It is not a ranking and not an efficacy comparison between brands.
Medical care at Abijou
Care is provided by the medical team at the branch you select. These clinicians lead the three branches linked from this guide; confirm the doctor assigned to your visit with that branch.
Chief MD, Myeongdong
Cheol-su Yoon
I want to be thinking about how the patient feels right up to the last moment of the procedure.
Chief MD, Hongdae
Jae-wook Kim
I will give my best with the attentiveness to catch even the smallest change.
Listed branch medical team — not a medical-review byline for this article.
Frequently asked questions
Who makes Ultherapy PRIME, and what does the official name actually say?
The 510(k) applicant on the U.S. record is Ulthera Inc., and Merz Aesthetics announced the platform launch on 23 September 2024. The name on that record is “Ulthera System (UC-1 Control Unit PRIME)”, so PRIME refers to the control unit rather than to a separate treatment brand. In Chinese-speaking markets Merz Aesthetics Taiwan markets it as Ultherapy PRIME 美國音波極透+.
Is “Ultherapy” the name of a machine or of a procedure?
It is a device system brand that clinics also use loosely as a procedure name. The device record covers a system — a control unit with transducers — so booking under the brand name still leaves the control unit model, the transducer depths and the number of lines unspecified. Ask for those three details in writing before you agree to anything.
What does the “visualization” part of MFU-V actually do?
It lets the operator see the tissue layers on screen before energy is delivered, so placement is based on what is under the skin at that spot. Merz Korea names this real-time imaging function DeepSEE, and the official physician material describes visualization as part of how the system is used. It is a placement aid; it does not make any result certain.
How is PRIME different from the earlier Ultherapy generation?
The published difference sits in the hardware and the interface, not in what the treatment is cleared to do. Merz describes treatments that are 20% faster and a 35% larger screen with a faster image refresh rate, and the U.S. indication wording quoted at launch is the same wording used before. Those percentages compare machines with each other and cannot tell you how a session will turn out.
Is every treatment sold as “HIFU” the same as Ultherapy PRIME?
No — HIFU is a category word for focused-ultrasound devices and does not identify a manufacturer or a model. The one feature the official material puts forward as distinguishing is real-time visualization of tissue layers before energy delivery. This page holds no data comparing Ultherapy PRIME with other brands, so ask for the device and model name in writing instead of relying on the category word.
If a clinic uses its own menu name for ultrasound lifting, is that the same treatment?
Not necessarily, because a menu name is a marketing label, not a device name. The same label can cover different machines, different transducer depths and different line counts, and this page has no information about any clinic-specific programme. Ask which control unit the programme runs on, which transducers are planned and how many lines each area receives, then compare those answers rather than the menu names.
How painful is it?
Discomfort is reported during energy delivery rather than after it, and the 2024 meta-analysis found a pooled mean pain score of 4.85 out of 10. That figure pools studies using different settings, areas and protocols, so it describes the published literature rather than what one appointment will feel like. Ask the clinic what pain management they use and whether it changes the plan.
Is there downtime, and can I fly home the same week?
The sources used on this page do not publish a downtime schedule, so the clinic that treats you has to give you that timing. Share your travel dates before booking, because the answer depends on the areas treated and the plan rather than on the brand name. Ask in the same conversation which symptoms should make you call, and how follow-up works once you have flown home.
How many sessions are standard, and how soon can a treatment be repeated?
The sources here do not set a standard session count or a fixed interval; that is a clinical decision for your areas and plan. What the literature does describe is its own observation window: the pooled review covers follow-up from immediately after treatment to about 365 days, roughly 80% of it inside six months, and the randomised split-body trial followed people to six months. A window of observation is not a promised duration.
What should I tell the clinic before booking?
Raise pregnancy or breastfeeding, active skin infection or open or inflamed skin in the treatment area, implants or devices in or near that area, medicines that affect bleeding or healing, and recent fillers, toxins, lasers or other energy treatments. The sources on this page do not publish a contraindication list, so these are disclosure topics that let a clinician judge suitability and timing in person rather than a formal exclusion list.
Is it risk-free because nothing is cut?
No — non-surgical does not mean risk-free. Energy is delivered below the skin surface, discomfort during treatment is documented in the pooled literature, and complications are possible with any energy device. Ask the treating clinic which adverse effects they see, how they manage them, and who you contact outside opening hours.
Does “FDA-cleared” mean the treatment is proven to work?
No — it is a marketing authorisation based on substantial equivalence, not a verdict on results. K233996 was decided substantially equivalent on 22 February 2024 under product code OHV and 21 CFR 878.4590, and K243035 followed on 24 February 2025 for the body areas. Evidence of effect is a separate question, and the pooled review answering it rests mostly on uncontrolled before-and-after studies.
How do I compare Ultherapy PRIME quotes between clinics?
Align what each quote contains before you compare the amounts. Confirm the control unit model, the transducer depths planned (1.5 mm, 3.0 mm, 4.5 mm), the number of lines per area, which areas are included, whether the quote covers one session or a package, and what follow-up is included. Quotes built on different depths, line counts or areas are not the same treatment, so the numbers are not comparable until those details match.
Who is this for, and can I have it during a short trip to Korea?
Suitability is decided at an in-person assessment, including for short trips. Bring your travel dates, medicines, medical history and recent procedures, and ask what the plan would be for your areas, what follow-up it would need, and what to do if a question arises after you fly home. No clinic can judge suitability from a brand name or a photo alone.
How Abijou works
We started in Gangnam in 2006 and the network now runs 17 branches across Korea. The line we work to is skin transformation woven into everyday life — care you can keep up with, rather than one dramatic change.
- Across the 17 branches in Seoul, Gyeonggi, Incheon and Busan: over 1,000 medical professionals and more than 350 certified medical devices
- Authentic products only, in appropriate amounts — the treatment is fitted to the condition, not to a package
- Prices are quoted from each branch’s published price list as it stands
Contact and location
- Phone
- 1544-0377
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