Category: Procedures

Note №31REGULATORY RECORD

Four Korean RF devices sold as skin tightening carry United States clearances. Read the cleared sentence and it says electrocoagulation and hemostasis — the surgical control of bleeding. Here is the exact wording of each, and what it does and does not tell you.

You are sitting in a consultation room in Gangnam. The 상담실장 (sangdamsiljang) — the consultation manager, the one who quotes the price, and not the doctor — turns a tablet toward you. On the screen is a device you have never heard of: 볼뉴머 (Volnewmer), or 덴서티 (DENSITY), or 올리지오 (Oligio), or 텐써마 (10THERMA). Under the product photograph, in English, are two words you recognise: FDA cleared.

Those two words are true. You can look the clearance up yourself in ten minutes, and this article will show you how. But the sentence the FDA actually cleared does not contain the words lifting, tightening, wrinkle, or skin laxity. For three of these four devices, it contains only this: electrocoagulation and hemostasis — burning tissue closed, and stopping bleeding.

What is actually inside an FDA clearance?

A 510(k) clearance is a finding that a new device is substantially equivalent to one already legally on the US market. It is not a finding that the device works.

Every clearance carries one short, formal sentence called Indications for Use. That sentence — not the brochure, not the clinic’s website — is the legal description of what the device is cleared to do. It is published as a PDF on the FDA’s own server, and anyone can read it.

This matters because “cleared” and “approved” are different things, and Korean clinic marketing in English uses them interchangeably. We have written before about what a Korean clinic menu is actually listing, and about treatments where the FDA approval count is zero.

What were the four Korean devices cleared for?

Here is the Indications for Use text, quoted exactly, from each clearance document.

Device	510(k)	Cleared	Indications for Use — verbatim
볼뉴머 Volnewmer (CLASSYS)	K240248	29 Apr 2024	“Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.”
덴서티 DENSITY (Jeisys Medical)	K230663	14 Aug 2023	“DENSITY indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.”
올리지오 X Oligio X (Won Tech)	K240313	22 Feb 2024	“The ‘Oligio X is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.”
텐써마 10THERMA (Tentech)	K232992	20 Dec 2023	“10THERMA indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.”

Four devices, four different manufacturers, four clearances issued inside nine months of each other. Not one of the four sentences mentions a wrinkle.

Why does Thermage have wrinkle indications when these do not?

Because Thermage was cleared for them separately, and the devices that cite it did not ask for the same list.

써마지 (Thermage) FLX, made by Solta Medical, was cleared in 2017. Its Indications for Use is long, and it says this explicitly:

“Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; Non-invasive treatment of wrinkles and rhytids.”

The mode that applies RF and vibration at the same time adds “Temporary improvement in the appearance of cellulite,” relief of minor muscle aches, relief of muscle spasms, and temporary improvement of local circulation.

Three of the four Korean devices name Thermage FLX (K170758) directly as their predicate device: Volnewmer, DENSITY, and 10THERMA. The fourth, Oligio X, names an earlier Won Tech model, The Oligio (K221989, cleared 13 Oct 2022) — and that clearance names Thermage FLX. So the lineage reaches Thermage in every case; for Oligio X it takes one extra step.

A predicate is an ancestor, not an inheritance. Citing a device does not transfer that device’s indication list to yours. We could not find an FDA statement explaining why these four sought the narrower wording, and we are not going to guess at the reason.

Is InMode different?

Yes — and not in the way you would expect. 인모드 (InMode) is not one device. It is a console with interchangeable handpieces, and each handpiece was cleared for something different under a single 2022 clearance.

Handpiece	Indications for Use — verbatim
Forma (Plus, Plus90, Plus-Plus)	“indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.”
Morpheus8	“intended for use in dermatological procedures for electrocoagulation and hemostasis.”
Fractora 3D	“intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.”
FaceFX (WMFace)	“intended for use in dermatologic procedures, for noninvasive treatment of mild to moderate facial wrinkles and rhytids.”
BodyFX	“…Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation. Temporary reduction in the appearance of cellulite.”

Forma is one of the handpieces sold in Korea as a lifting treatment. In its US clearance it is a muscle-ache and blood-circulation device. Morpheus8, the most internationally famous name on this list, is cleared for electrocoagulation and hemostasis. FaceFX is the only handpiece in the table whose cleared sentence contains the word “wrinkles.”

If a clinic tells you the machine is FDA-cleared, that statement can be true while the specific handpiece being used on your face is cleared for something else entirely.

Does this mean the devices do not work?

No. This article does not say that, and cannot.

Three things are true at once, and they need to be kept apart:

1. In the United States, using a device outside its cleared indications is lawful. A licensed physician there may use a cleared device for a purpose the clearance does not list; this is ordinary medical practice, not a violation. We did not verify how Korea treats off-label device use, and we make no claim about it here.
2. A clearance is not an efficacy verdict. A 510(k) says a device is substantially equivalent to an earlier one. The absence of a wrinkle indication is not evidence that a device fails to tighten skin. It is evidence about a regulatory filing, and nothing more.
3. We did not check Korean approvals. These devices are used in Korea under Korean regulation, and 식약처 (MFDS) — Korea’s drug and device authority — makes its own determinations. We did not look up what any of these devices are approved for in Korea, and nothing here should be read as a claim about their Korean status.

What this article says is narrower, and we think more useful: the two English words on the tablet do not mean what a foreign patient reasonably assumes they mean, and the document that says what they do mean is free, public, and four clicks away.

What can you ask before the treatment?

Ask for the exact model name in English, not the Korean product name. The two often differ, and a device sold under one name in Korea may be exported under another — we have written about what happens to device names at the border.

Then, if the clinic has told you the device is FDA-cleared:

• Ask for the K-number. Every clearance has one, in the format K + six digits. A clinic making the claim should be able to produce it.
• Read the sentence yourself. Search the K-number at accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm, then open the linked PDF and find “Indications for Use.” It is one paragraph.
• For InMode, ask which handpiece. The console clearance and the handpiece clearance are not the same question.
• Ask what the device is approved for in Korea. That is the regulation you are actually being treated under. We did not research this; the clinic can tell you, and 식약처 maintains the record.

None of this makes a treatment better or worse. It changes what you are agreeing to — from a marketing phrase to a document you have read.

Common questions

Is “FDA-cleared” the same as “FDA-approved”?

No. Clearance (510(k)) is a finding of substantial equivalence to an existing device. Approval (PMA) is a separate, much heavier review pathway. Korean clinic marketing in English frequently uses “approved” where the record says “cleared.”

Does electrocoagulation and hemostasis mean the device is a surgical tool?

It means the cleared use is burning tissue closed and stopping bleeding. Whether a given device is also effective for skin tightening is a separate question that the clearance document does not answer either way.

Are these devices unsafe?

Nothing in this article supports that conclusion. A narrow indications statement is a fact about a regulatory filing, not a safety finding. We did not review any safety data.

Are these devices unapproved in Korea?

We do not know. We did not check the 식약처 (MFDS) record for any of them. Do not read a US clearance’s wording as a statement about Korean approval.

Which lifting device should I choose?

We do not make treatment recommendations and will not start here. What this article gives you is a way to check one specific claim — the FDA one — against its source.

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Sources

All FDA documents accessed 19 August 2026.

• Volnewmer, K240248 (CLASSYS Inc., cleared 29 April 2024) — https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240248.pdf
• DENSITY, K230663 (Jeisys Medical Inc., cleared 14 August 2023) — https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230663.pdf
• Oligio X, K240313 (Won Tech Co., Ltd., cleared 22 February 2024) — https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240313.pdf
• The Oligio, K221989 (Won Tech Co., Ltd., cleared 13 October 2022) — https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221989.pdf
• 10THERMA, K232992 (Tentech Inc., cleared 20 December 2023) — https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232992.pdf
• Thermage FLX System, K170758 (Solta Medical Inc., cleared 22 September 2017) — https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170758.pdf
• InMode Multi System, K221571 (InMode Ltd., cleared 30 June 2022) — https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221571.pdf
• FDA, Premarket Notification 510(k) — https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k
• FDA 510(k) Premarket Notification database — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

The clearance sentence is one half of what a clinic tells you about a machine. The other half is the number on the quote — and a Korean lifting price is counted in shots, not treatments.

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The Clinic Notes — verified, source-cited information on cosmetic medicine in South Korea. We accept no payments or benefits from clinics, hospitals, doctors, or referral agencies.

Note №29REGULATORY RECORD

You had HIFU lifting in Seoul. Back home, you tell your dermatologist you had “Shurink.” They have never heard of it — and neither has any regulator in their country. That is not because the machine is obscure. It is because in Korean clinics, several of the most common device and product names change — or quietly stop existing — the moment you cross a border.

We have verified each example below against primary regulatory records for earlier articles on this site; this piece collects them in one place, because the pattern itself is the useful knowledge.

Same machine, different passport

Name on the Korean menu	What it is elsewhere
슈링크 (Shurink)	Sold abroad as Ultraformer. No FDA clearance exists under either name; the manufacturer’s US-cleared devices are different models entirely
울쎄라 (Ulthera)	Real US device — but authorised via a De Novo pathway (2009) and later 510(k)s, which is not the same thing as “FDA approved”
써마지 (Thermage)	US 510(k)-cleared — with cleared indications that do not include the lifting language Korean marketing uses
리쥬란 (Rejuran)	Long called “Asia-only” — no longer true: it obtained EU CE marking under the MDR in December 2024. It remains unavailable in the US
스컬트라 (Sculptra)	The rare one with a full FDA premarket approval (PMA)

Why this matters more than trivia

• Your aftercare depends on it. A doctor at home cannot look up “Shurink.” Ask your Korean clinic to write down the device’s export name and the treatment parameters — and keep it with your treatment records.
• “FDA approved” usually is not. Most aesthetic devices reach the US market through clearance pathways (510(k), De Novo) that involve far less evidence than approval. When a clinic’s English page says “FDA approved,” the accurate word is usually “cleared” — and sometimes neither applies to the Korean-market model at all.
• Names are marketing territory. Korean treatment menus already run on nickname conventions; device branding by market is one more layer. None of this means the treatment is bad — it means the name alone is not information.

What this article does not claim

Nothing here says these devices are unsafe or ineffective, and no clinic is named. Regulatory status describes what a regulator has reviewed — not how good the treatment is. Statuses also change; the entries above reflect records as verified for our earlier coverage and re-checked on the date below.

Sources and last verification

• FDA device databases (De Novo DEN080006 for Ultherapy; 510(k) K170758 for Thermage FLX; PMA P030050/S039 for Sculptra) — verified for earlier articles on this site — re-checked 18 August 2026
• EU CE MDR certification of Rejuran (26 December 2024) — manufacturer announcement, previously verified — accessed 18 August 2026
• Classys (Shurink/Ultraformer manufacturer) US clearance records — previously verified: no clearance under the Shurink or Ultraformer names — accessed 18 August 2026

A name is only the first layer. The regulatory sentence attached to a device can be narrower still: we read the clearance text for four Korean radiofrequency devices and not one of them mentions a wrinkle.

Verified 18 August 2026. Regulatory statuses change; check the FDA and EU databases for the current record.

Related. One layer below the name is the packaging. Korean law fixes what must be printed on a device box and on a drug vial — and two of those items can be checked against a public database before treatment: what to read on the box, and what opening it does not prove.

Note №17REGULATORY RECORD

Korean clinics sell IV drips under nicknames — 백옥주사 (baegok jusa, “white jade injection”), 신데렐라주사 (sinderella jusa, “Cinderella injection”) — rather than product names. We read one glutathione injection’s licence in Korea’s drug database in full on 13 August 2026: its only approved indication is preventing nerve damage caused by cisplatin-type chemotherapy. It does not mention skin. Korea regulates off-label prescribing rather than banning it — the health-insurance rules set out an approval route through the institution’s review board and the review agency. What the gap tells you is that no regulator has evaluated the use being sold to you.

Walk into a Korean clinic for a vitamin drip and you will be offered items with nicknames. 백옥주사 — the “white jade injection.” 신데렐라주사 — the “Cinderella injection.” 마늘주사 — the “garlic injection.” The names describe an outcome, or a smell, and they are what appears on the price board.

None of them is a product name. Each is a nickname for a prescription drug that Korea’s Ministry of Food and Drug Safety licensed for something specific — and in at least one case we were able to read in full, the licence does not mention skin at all.

What is 백옥주사 (baegok jusa) actually licensed for?

백옥주사 is glutathione. We looked up a glutathione injection in the ministry’s own drug database and read its approved indication.

라이트타치온주1200밀리그램 (글루타티온(환원형)) — Mothers Pharmaceutical, licensed 24 January 2017. The approved indication, in full:

시스플라틴 또는 유사계열 화학요법에 의한 신경성질환의 예방

Prevention of neurological disorders caused by cisplatin or similar chemotherapy.

That is the entire licensed indication for 라이트타치온주1200밀리그램. It is a supportive drug for cancer patients on platinum-based chemotherapy, given to protect their nerves. There is no line about pigmentation, brightness, tone, or skin of any kind.

The drug being sold to you as a whitening treatment is licensed to stop chemotherapy from damaging nerves.

This is not an accusation

It needs saying plainly, because the gap above is easy to misread.

Korea regulates prescribing outside a licence rather than prohibiting it. The route is written into the health-insurance rules: under the Rules on the Standards for Medical Care Benefits under National Health Insurance, Article 9(1), what is excluded from benefit coverage is listed in Table 2 — and the Health Insurance Review and Assessment Service publishes the procedure that sits on top of that clause for drugs used beyond their licensed range. As HIRA describes it, the institution clears its own institutional review board, files with HIRA within fifteen days, the Ministry of Food and Drug Safety reviews safety and efficacy, HIRA issues the decision, and the institution reports its usage once a year. A licence reflects what a manufacturer applied and paid to prove, not the boundary of what a substance can do. Nothing here says the injection is unsafe, and nothing here says it does or does not work. We are not in a position to tell you either, and we are not going to guess.

What we did not verify. That procedure is written for drugs used inside the national health insurance system. We did not establish how — or whether — it reaches a purely cosmetic, self-paid drip in a private clinic, and we are not claiming that the drips on a Korean price board have been through it. We are also not claiming that any of them is unlawful.

What the gap does tell you is narrower, and it is still worth carrying:

• The regulator has not evaluated the use you are buying. When a drug is given for its licensed purpose, an agency has reviewed evidence for that purpose. Off-label, that review does not exist. The claim rests on the clinic.
• The marketing language is not regulated language. “Whitening,” “glow,” “detox,” “immunity” are sales words. They do not appear in the licence, and no agency has signed off on them.
• You are the one carrying the difference. Which is a reason to ask what is in the bag, not a reason to walk out.

The nicknames, decoded: what is in a Korean beauty drip?

We are listing what each nickname refers to and what it is marketed for. We are not stating what any of them does.

On the price board	Romanised	Literally	Active substance	Sold as
백옥주사	baegok jusa	“white jade injection”	Glutathione	Brightening, “whitening”
신데렐라주사	sinderella jusa	“Cinderella injection”	Thioctic acid (alpha-lipoic acid)	Fatigue, slimming, “anti-ageing”
마늘주사	maneul jusa	“garlic injection”	Thiamine derivative (fursultiamine)	Fatigue, hangover, energy
감초주사	gamcho jusa	“licorice injection”	Glycyrrhizin	Liver support, skin
수액 / 링거	suaek / ringgeo	“fluid” / “Ringer’s”	Saline or Ringer’s base, plus additives	Hangover, cold, general recovery

The last row — 수액 / 링거 — is the one to watch, because it names the container rather than the contents. A “링거” is a base fluid. What matters is what has been added to it, and that is a question, not a menu item.

What we could not check

We read one licence in full — the glutathione injection 라이트타치온주1200밀리그램. We were not able to read the approved indication text for the others.

The ministry’s public database, 의약품안전나라, returns its product-detail pages in a form that does not render without a browser session, so the indication field could not be retrieved for the thioctic acid injection (부광치옥타시드주, Bukwang Pharmaceutical) or for the others in the table. We confirmed those products exist and are injections. We did not read what they are licensed to treat, so we are not telling you.

We are also not telling you that every glutathione injection carries the wording above. We read one product’s licence. Others may be worded differently.

If a number or an indication matters to your decision, the clinic can show you the licence for the specific product it is about to use. That request is ordinary and answerable.

What to ask before the needle

1. “What is the product name, and what is the active ingredient?” The nickname answers neither. This is the same problem we described in Korean clinic menus that list product names rather than treatments.
2. “What is this licensed for in Korea?” Not what it is used for. What the licence says.
3. “Is this being given off-label?” A clinic comfortable with the answer will simply say yes and explain why. That is a better sign than a clinic that does not understand the question.
4. “What is the dose, and what else is in the bag?” Particularly for anything sold as 링거.
5. “Can I have this written down?” You will want it if anything needs following up at home — and you can obtain your records after you fly out.

If a drip is sold to you as part of a prepaid package of sessions, the money side has its own well-documented failure mode — refunds, not complications, are what people actually end up disputing.

Common questions

What is 백옥주사, the “white jade injection”?

It is a nickname, not a product name. The active substance is glutathione, and it is marketed in Korean clinics for brightening or “whitening.” We are describing what it is sold as, not what it does.

Is glutathione licensed for skin whitening in Korea?

The one product we read in full is not. 라이트타치온주1200밀리그램 (Mothers Pharmaceutical, licensed 24 January 2017) carries a single approved indication — prevention of neurological disorders caused by cisplatin or similar chemotherapy — and no mention of skin. We read one product’s licence on 13 August 2026; other glutathione products may be worded differently, and we are not claiming otherwise.

Is it legal for a Korean clinic to give a drip off-label?

Korea regulates off-label use rather than banning it. The health-insurance rules (Rules on the Standards for Medical Care Benefits under National Health Insurance, Article 9(1) and Table 2) sit under a published procedure in which a medical institution clears its own review board, files with the Health Insurance Review and Assessment Service, and receives a decision after the Ministry of Food and Drug Safety reviews safety and efficacy. We did not establish how that procedure applies to a purely cosmetic, self-paid drip. The consequence for a patient is narrower: where a use is off-label, no agency has reviewed evidence for that use, so the claim rests on the clinic rather than on the regulator.

What is in a 링거 (ringgeo) drip?

링거 names the base fluid — saline or a Ringer’s solution — not the contents. What matters is what has been added to it, which is a question for the clinic rather than a line on the price board.

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The Clinic Notes — verified, source-cited information on cosmetic medicine in South Korea. We accept no payments or benefits from clinics, hospitals, doctors, or referral agencies.

Sources: Ministry of Food and Drug Safety, 의약품안전나라 (Drug Safety Information system), product licence record for 라이트타치온주1200밀리그램(글루타티온(환원형)), Mothers Pharmaceutical, licensed 24 January 2017 — indication text read in the original, 13 August 2026. Existence and dosage form of 부광치옥타시드주(티옥트산트로메타민), Bukwang Pharmaceutical, confirmed in the same database on the same date; its indication text could not be retrieved. Nicknames and their marketed uses are as advertised by clinics and are not regulator language. Rules on the Standards for Medical Care Benefits under National Health Insurance, Article 9(1), read in the original on the National Law Information Center, 21 August 2026 (https://www.law.go.kr/법령/국민건강보험요양급여의기준에관한규칙). Approval procedure for use beyond a licensed range as described by the Health Insurance Review and Assessment Service, read 21 August 2026 (https://biz.hira.or.kr/contents/html/MP00000730.html).

Note №16MENU DECODER

Most lines on a Korean clinic price list are product names — specific machines and specific syringes from named manufacturers — not procedure names. One of them, 슈링크 (Shurink), is sold outside Korea as Ultraformer; both names occupy the same slot in one manufacturer’s catalogue — CLASSYS. Neither name appears in the FDA’s device databases, which we queried on 13 August 2026.

You will be handed a price list — printed, laminated, or on a tablet — and most lines on it will be words you have never seen. 리쥬란. 슈링크. 인모드. 물광주사. 쥬베룩. Ask what one of them is, and you will usually get the same word back, said more slowly.

They are not procedure names. They are product names — specific machines and specific syringes, each made by a specific company. That single reframe makes the menu readable. You are not choosing between treatments. You are being quoted for named products, the way a garage quotes you a brand of tire.

And at least one of those products is sold under a different name the moment it leaves the country. Same manufacturer, same catalogue, two names — which is why searching the Korean term in English so often returns nothing useful.

The decoder: what each name on a Korean clinic menu actually is

On the menu	Romanized	Literally	What it is	Sold elsewhere as
리쥬란	Rejuran	(brand)	Injectable containing polynucleotides derived from salmon DNA, marketed for skin quality rather than volume	Rejuran (same name)
물광주사	mulgwang jusa	“water-glow injection”	Many small hyaluronic acid injections spread across the face	skin booster
스킨보톡스	skin botox	—	Botulinum toxin placed shallowly in many small doses across an area, rather than into a specific muscle	microtox, mesobotox
슈링크	Shurink	(brand)	Focused-ultrasound lifting device	Ultraformer — see below
울쎄라	Ulthera	(brand)	Focused-ultrasound lifting device	Ultherapy
인모드	InMode	(brand)	Radiofrequency platform with several handpieces	InMode
쥬베룩	Juvelook	(brand)	Injectable collagen stimulator	Juvelook
아쿠아퓨어	Aquapure	(brand)	Cleansing-and-infusion facial device	Aquapure
엑소좀	exosome	—	Add-on marketed for skin repair	exosome

슈링크 and 울쎄라 are the same category of machine: both deliver focused ultrasound. They are usually priced far apart. Nothing on the menu tells you why.

Why is 슈링크 (Shurink) called Ultraformer outside Korea?

슈링크 is made by CLASSYS, a Korean manufacturer of clinic devices. The company runs two catalogues, and we read both on the same day.

On the Korean site, the medical lineup opens with 슈링크 유니버스 and 슈링크, followed by 볼뉴머, 시크릿 RF, 아쿠아퓨어, 사이저, 리핏, 울핏.

On the global English site, the same catalogue reads: ULTRAFORMER MPT, ULTRAFORMER III, VOLNEWMER, SECRET RF, AQUAPURE, SCIZER, REFIT, ULFIT.

Line them up:

Korean catalogue	Global catalogue
볼뉴머	VOLNEWMER
시크릿 RF	SECRET RF
아쿠아퓨어	AQUAPURE
사이저	SCIZER
리핏	REFIT
울핏	ULFIT
슈링크 / 슈링크 유니버스	ULTRAFORMER III / ULTRAFORMER MPT

Every other CLASSYS product is a straight transliteration of the same name. The flagship lifting device is the exception: 슈링크 and 슈링크 유니버스 appear on the global catalogue as ULTRAFORMER III and ULTRAFORMER MPT. The global site lists no clinic device called Shurink at all — the only Shurink entry there is SHURINKHOME, a home-use product.

We are describing what the two catalogues say, not certifying that a given Korean model and a given export model are identical hardware. If that matters to you, it is a question for the clinic, and the answer should be a model name you can write down.

Are Korean clinic devices FDA approved?

American readers ask whether these are “FDA approved.” That phrase does more harm than good here, because the answer is different for every line on the menu. So we searched the FDA’s own databases, by device name and by company, on 13 August 2026.

The short version: Ulthera and InMode appear in the FDA’s databases; Shurink, Ultraformer, Rejuran and Juvelook do not. The full result:

Product	Company	Found in FDA databases?
Ulthera System	Ulthera, Inc. (Merz)	Yes. Authorized in 2009 (DEN080006), with further clearances through 2026 — the most recent K260618, 21 May 2026
InMode devices	InMode Ltd / Inmode MD Ltd	Yes. Multiple clearances, including K151273 and K201150
Shurink / Ultraformer	CLASSYS, Inc.	No record under either name
Rejuran	PharmaResearch	No record under that device name or that company
Juvelook	VAIM	No record under that device name or that company
Exosome products	various	None — covered in full here

Read that table carefully. It is easy to see something in it that is not there. CLASSYS holds four 510(k) clearances — SCIZER, Volnewmer (twice) and CuRAS hybrid — and none of them is named Shurink or Ultraformer.

Absence from a US database is not a safety finding. It means the product was not put through a US review — usually because it was never marketed there. Devices used in Korean clinics are licensed by Korea’s Ministry of Food and Drug Safety, a separate regulator with its own process. A machine can be entirely lawful in a Seoul clinic and simply absent from Washington’s filing cabinet.

What the table does tell you is this: the phrase “FDA approved” cannot be applied to a Korean clinic menu as a whole. For 울쎄라 it is true and the manufacturer publishes exactly which body areas it covers. For most of the rest, there is nothing in those databases to point at. If a clinic’s English page attaches “FDA” to the menu in general rather than to one named product, that is a claim worth asking them to narrow.

What we could not verify

We did not independently check each product’s Korean licence in the Ministry of Food and Drug Safety’s own database. This article therefore makes no claim about Korean approval status for any product named above, and no claim about what any of them does to skin.

We also found no published, comparable price for these treatments. Korean clinics generally do not post cosmetic prices, and the ones that circulate in English blogs are not sourced. We have not repeated them here.

Drips run on the same naming logic, and their labels hide a different gap: a Korean beauty drip’s licence says nothing about beauty.

What to ask before you agree to anything

Five questions, none of which requires you to know anything about the technology:

1. “What is the model name of the device?” Not the treatment name — the machine. Write it down. You can search it later.
2. “Who makes it?” A named company is a checkable answer. “It’s the latest model” is not.
3. “Is this the product itself, or a treatment that uses it?” Clinics sometimes name a package after a device it only partly involves.
4. “How many sessions is this price for, and what happens to the balance if I stop?” Prepayment is the single most common source of disputes at Korean clinics, and in July 2026 Korea’s Fair Trade Commission got fifteen named clinics to drop their no-refund clauses — a correction to those fifteen contracts, not a change in the law. Assume yours still says whatever it says.
5. “Can I have this in writing before I fly home?” You are entitled to your records, including after you leave.

A clinic that answers the first two without hesitation has told you more than any review will. And reviews, in this market, are their own problem.

Common questions

Is 슈링크 (Shurink) the same as Ultraformer?

They are the same manufacturer’s catalogue entries under two names. CLASSYS lists 슈링크 and 슈링크 유니버스 on its Korean site, and ULTRAFORMER III and ULTRAFORMER MPT in the same catalogue position on its global site. We are describing what the two catalogues say, not certifying that a given Korean model and a given export model are identical hardware.

Is Rejuran FDA approved?

We found no record of Rejuran, or of its maker PharmaResearch, in the FDA’s 510(k) or PMA databases when we queried them on 13 August 2026. Absence from a US database is not a safety finding — it usually means the product was never marketed in the United States. Devices used in Korean clinics are licensed by Korea’s Ministry of Food and Drug Safety, a separate regulator.

What is the difference between 슈링크 (Shurink) and 울쎄라 (Ulthera)?

Both deliver focused ultrasound and both are lifting devices, but they are made by different companies — CLASSYS and Ulthera, Inc. (Merz). They are usually priced far apart, and a Korean clinic menu does not normally explain why.

Why do Korean treatment names return nothing when I search them in English?

Because most of them are product names rather than procedure names, and at least one is sold under a different name outside Korea. Searching 슈링크 in English will not surface Ultraformer, even though the manufacturer’s own two catalogues place them in the same position.

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Sources

All accessed 13 August 2026.

• CLASSYS Inc., Korean product catalogue — https://classys.co.kr/
• CLASSYS Inc., global product catalogue — https://www.classys.com/
• Merz Aesthetics, Ultherapy official site (manufacturer’s own statement of FDA-cleared uses) — https://www.ultherapy.com/
• US FDA, 510(k) Premarket Notification database, queried via openFDA — https://api.fda.gov/device/510k.json
• US FDA, Premarket Approval (PMA) database, queried via openFDA — https://api.fda.gov/device/pma.json

Once you have a device’s real name, the next question is what its clearance actually says. We read the FDA wording for four Korean radiofrequency lifting devices and found it describes stopping bleeding.