Walk into a Seoul clinic and ask about lifting, and you will hear four names within about a minute: Ultherapy, Shurink, Thermage, ONDA. You will also hear what each one does — tightening, contouring, fat, collagen.
Korea’s medical device regulator has a view on those claims. It is written down, it is public, and it is narrower than what you will be told across the consultation table.
Neither version is dishonest. But they are different documents, and knowing which one you are hearing changes how you listen.
What the approval is, and what it is not
Every medical device sold in Korea carries an approval from the Ministry of Food and Drug Safety — 식품의약품안전처, usually shortened to MFDS. Each approval has a number, a device class, and a line called 사용목적: the stated purpose.
That line is the regulator’s answer to a narrow question — what did the manufacturer submit evidence for, and what was accepted. It is not a description of everything the machine can do, and it is not a judgement about whether the treatment works.
It is simply the shortest honest answer to “approved for what, exactly?” — and it is the one thing in this whole area that is not marketing.
The four devices, and what each is approved for
We looked each one up in the MFDS database in August 2026. Translations below are ours; the approval numbers let you check.
| Device | Approval | Stated purpose |
|---|---|---|
| Ultherapy 울쎄라 |
수허 09-1024 (2009) |
Coagulating tissue with focused ultrasound to lift the eyebrow, the sagging jawline and the upper chest, and to improve wrinkles on the décolleté |
| Shurink Universe 슈링크 유니버스 |
제허 21-831 (2021) |
Written per cartridge. Eyebrow lift; improvement of wrinkles around the eyes, mouth and neck; improvement of skin and subcutaneous tissue elasticity on the abdomen and thighs |
| Thermage FLX 써마지 FLX |
수허 18-245 (2018) |
Using radiofrequency current to coagulate tissue for the non-invasive treatment of wrinkles around the eyes and on the face |
| ONDA 온다 |
수인 22-4482 (2022) 수인 24-369 (2024) 수허 26-28 (2026) |
Applying 2,450 MHz electromagnetic energy to the body for pain relief. The 2026 approval adds tissue coagulation |
Three things that fall out of the table
1. Every approval is more specific than “lifting”
Ultherapy is not approved for the face. It is approved for the eyebrow, the jawline and the upper chest — three named areas.
Thermage FLX is approved for wrinkles, not for tightening or contouring. Shurink’s abdomen and thigh approval is for elasticity of skin and subcutaneous tissue, which is a different claim from fat reduction.
None of this makes a clinic wrong to use a device elsewhere. It does mean that when someone says a device is “approved for” a particular result, there is a document that either says that or does not.
2. Shurink’s approval is written cartridge by cartridge
This is the most practically useful thing in the whole table, and almost nobody mentions it.
The Shurink Universe approval does not describe the machine as a whole. It lists which cartridge is approved for which purpose. The eyebrow-lift cartridges are named individually. A different cartridge covers wrinkles around the eyes, mouth and neck. Two more cover abdomen and thigh elasticity.
Same machine. Change the cartridge and you are inside a different approval.
Which makes “which cartridge will you use?” a substantive question rather than a fussy one — and it explains why two Shurink quotes for the same face can differ so much. They may not be describing the same treatment at all.
3. ONDA’s approval is for pain relief
Of the four, this is the widest gap between the document and the sales pitch.
ONDA is sold in Korea as a body-contouring device — localised fat, cellulite, skin tightening. All three of its Korean approvals describe something else: applying microwave energy for pain relief, with tissue coagulation added in the newest one.
The United States tells the same story. ONDA PRO is listed with the FDA under clearance K260647 (April 2026), filed under the device name SPECCHIO — which is why searching the FDA database for “ONDA” returns nothing. Its product code covers heat “for minor relief of minor aches and pain” and massage giving “a temporary reduction in the appearance of cellulite.”
Fat reduction does not appear in either country’s paperwork.
What this does not mean
It would be easy to read the above as an accusation. It is not one, and getting this part right matters.
Using an approved device outside its stated purpose is normal, lawful and widespread — in Korea, in the United States, in Europe. A great deal of aesthetic medicine works this way, and much of it is well established in practice long before any manufacturer files for an expanded indication. Filing costs money and takes years; manufacturers do it when there is a commercial reason to, not whenever practice moves.
So the gap between the approval and the treatment menu is not evidence of anything improper. What it is evidence of is where the regulator’s assessment stops and the clinic’s judgement begins.
That line is worth being able to see.
How to use this in a consultation
Not as a challenge. As a way of getting a more specific answer than you would otherwise get.
- “Which cartridge or tip, and why that one?” — for anything cartridge-based. The answer tells you what depth is being targeted and what it is priced against.
- “Is this within the approved use, or beyond it?” — a clinician who knows their devices will answer this comfortably. There is no wrong answer, and hesitation is informative.
- “What are you basing the expected result on?” — if the answer is the approval, you can look it up. If it is clinical experience, that is a legitimate answer and a different one.
The point of all three is the same. You are not trying to catch anyone out. You are trying to find out whether the person in front of you is describing a document, a study, or their own hands — and all three are reasonable, but they are not interchangeable.
Looking it up yourself
The MFDS runs a public database of device approvals. It is Korean-language and the interface is not friendly, but the approval numbers above are searchable and the 사용목적 field is the one to read.
One caution for anyone checking a device we have not covered: brand names and approval names do not always match. ONDA’s US clearance is filed as SPECCHIO. Shurink’s earlier approval is filed under a different product name again. If a search returns nothing, the device may still be approved under a name you have not been given.
Questions people ask
Does an approval mean the treatment works?
No. It means the manufacturer submitted evidence for a specific purpose and the regulator accepted it. It is a floor, not a verdict, and it says nothing about whether the treatment will do what you personally want.
If a device is used beyond its approval, is that a problem?
Not in itself. It is standard practice across aesthetic medicine everywhere. What matters is whether the clinician can explain the reasoning, and whether you were told which situation you are in.
Why do Korean and US approvals differ?
Different regulators, different submissions, different times. A manufacturer files separately in each market and does not always seek the same indications. Neither approval is the “real” one.
Should I avoid a clinic that overstates an approval?
We would not go that far from a single sentence on a website — marketing copy is often written by someone other than the clinician. But it is a reasonable thing to raise at consultation, and how it is handled tells you something.
Do these approvals expire?
Korean device approvals carry validity periods and are renewed. Ultherapy’s current term runs to late 2026, for example. Renewal is routine, but it does mean a record you looked up a while ago may have moved.
Sources — Ministry of Food and Drug Safety medical device approval records (울쎄라 수허 09-1024; 슈링크 유니버스 제허 21-831; 써마지 FLX 수허 18-245; 온다 수인 22-4482, 수인 24-369, 수허 26-28), retrieved August 2026. US FDA 510(k) database and product classification records for K260647. Translations of the 사용목적 field are ours and are not official. Approvals are amended and renewed; check the current record before relying on anything here.
KKUMI Blog is not a medical provider and its writers are not doctors. This article summarises public regulatory records and is not medical advice. Whether any treatment is appropriate for you is a clinical judgement. First published 5 August 2026.
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