Approved in Korea, approved at home?
Many products used in Seoul clinics are Korean brands that are little known abroad. This table shows, for 55 toxins, fillers, boosters, threads and devices, what the Korean, US, Australian and Japanese registers say, with a link to the record. It states registration only. It says nothing about how well a product works or whether it suits you.
Checked 2026-11-04. Full records, with every number and note: approval-status-2026-11.csv.
How to read the table
- Approved.
- The register shows an approval: an MFDS permit in Korea, an FDA approval in the US, a 承認 in Japan.
- Cleared.
- The usual US route for a device: an FDA 510(k) or De Novo clearance.
- On register.
- Included in the Australian Register of Therapeutic Goods (ARTG).
- Certified.
- A Japanese 認証, the route for some lower-risk devices.
- Not found.
- The register was searched under the product’s names and maker and showed nothing. A product can be sold abroad under another name, so this is not the same as banned.
- Not checked.
- The register could not be searched on the check date. On 2026-11-04 the Australian register’s search was unreachable, so the Australian column shows only the 18 records that could be opened directly.
An approval covers the use written on the record. Several Korean radiofrequency devices, for example, are registered in Korea and the US as general electrosurgical devices for coagulating tissue rather than for lifting. The summary under each product says so where it applies.
Botulinum toxins
| Product | Korea (MFDS) | United States (FDA) | Australia (TGA) | Japan (PMDA) |
|---|---|---|---|---|
| Botox / Botox Cosmetic보톡스 · Allergan | Approved품목기준코드 200804190 | ApprovedBLA 103000 | On registerARTG 67311 | Approved22100AMX00398000 and 30800AMX00315000 |
| Approved in all four. In Japan the aesthetic product is Botox Vista. Treatment page | ||||
| Xeomin제오민 · Merz | Approved품목기준코드 200904004 | ApprovedBLA 125360 | On registerARTG 205508 | Approved30700AMX00126000 / 30700AMX00127000 / 30700AMX00128000 |
| Approved in all four. The Japanese approval is for medical uses only, with no cosmetic indication. Treatment page | ||||
| Dysport디스포트 · Ipsen | Approved품목기준코드 199907127 | ApprovedBLA 125274 | On registerARTG 235282 | Not checked |
| Approved in Korea, the US and Australia. Treatment page | ||||
| Botulax (US/EU: Letybo)보툴렉스 · Hugel | Approved품목기준코드 200901953 | ApprovedBLA 761225 | On registerARTG 370011 | Not checked |
| Korean brand. Approved in the US and Australia under the name Letybo. Treatment page | ||||
| Nabota (US: Jeuveau; AU: Nuceiva)나보타 · Daewoong Pharmaceutical | Approved품목기준코드 201310386 | ApprovedBLA 761085 | On registerARTG 381094 | Not checked |
| Korean brand. Approved in the US as Jeuveau and in Australia as Nuceiva. Treatment page | ||||
| Meditoxin메디톡신 · Medytox | Approved품목기준코드 200600841 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea. No US record found. Treatment page | ||||
| Coretox코어톡스 · Medytox | Approved품목기준코드 201603891 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea. No US record found. Treatment page | ||||
| Liztox리즈톡스 · Huons BioPharma | Approved품목기준코드 201605990 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea; exported as Hutox. No US record found. Treatment page | ||||
| Hitox하이톡스 · Korea BMI | Approved품목기준코드 202400165 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea in 2024. No US record found. Treatment page | ||||
| Newlux (뉴럭스)뉴럭스 · NUMECO | Approved품목기준코드 202302604 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea in 2023. No US record found. Treatment page | ||||
Fillers and collagen stimulators
| Product | Korea (MFDS) | United States (FDA) | Australia (TGA) | Japan (PMDA) |
|---|---|---|---|---|
| Restylane (Lidocaine)레스틸렌 · Galderma | Approved수허10-914호 | ApprovedPMA P040024/S039 | Not checked | Approved22700BZX00177000 |
| Approved in Korea, the US and Japan. Treatment page | ||||
| Juvederm Voluma / Volbella쥬비덤 · Allergan | Approved수허11-1452호 | ApprovedPMA P110033 | Not checked | Approved22800BZX00338000 |
| Approved in Korea, the US and Japan (as Juvéderm Vista). Treatment page | ||||
| Belotero Balance (Lidocaine)벨로테로 · Merz | Approved수허17-546호 | ApprovedPMA P090016 | Not checked | Not checked |
| Approved in Korea and the US. Treatment page | ||||
| Neuramis뉴라미스 · Medytox | Approved제허14-2923호 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea. No US record found. Treatment page | ||||
| YVOIRE이브아르 · LG Chem | Approved제허11-562호 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea. No US record found. Treatment page | ||||
| The Chaeum더채움 · Across | Approved제허14-860호 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea. No US record found. Treatment page | ||||
| Atiere아띠에르 · Medytox | Approved제허14-2923호 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea on the same permit as Neuramis. No US record found. Treatment page | ||||
| Rejuviel리쥬비엘 · PharmaResearch | Approved제허15-83호 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea. No US record found. Treatment page | ||||
| Radiesse레디어스 · Merz | Approved수허10-1238호 | ApprovedPMA P050052 | Not checked | Not checked |
| Approved in Korea and the US. Treatment page | ||||
| Sculptra스컬트라 · Galderma | Approved수허10-1161호 | ApprovedPMA P030050 | Not checked | Not checked |
| Approved in Korea, where it is a medical device, and in the US. Treatment page | ||||
| Juvelook / Juvelook Volume쥬베룩 / 쥬베룩볼륨 · Vaim | Approved제허17-972호 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea as a medical device. No US record found. Treatment page | ||||
| Lenisna레니스나 · Vaim | Approved제허17-972호 | Not found | Not checked | Not checked |
| Korean brand, on the Juvelook permit in Korea. No US record found. Treatment page | ||||
Skin boosters
| Product | Korea (MFDS) | United States (FDA) | Australia (TGA) | Japan (PMDA) |
|---|---|---|---|---|
| Rejuran Healer리쥬란 힐러 · PharmaResearch Co. Ltd | Approved제허14-825호 | Not found | On registerARTG 412630 | Not checked |
| Korean brand, approved in Korea as a tissue-repair material, and on the Australian register. No US record found. Treatment page | ||||
| Skinvive (Juvéderm Volite)스킨바이브 · Allergan | Approved수허18-134호 | ApprovedPMA P110033/S059 | On registerARTG 431913 | Approved30200BZX00389A01 |
| Approved in all four. Sold as Juvéderm Volite in some markets. Treatment page | ||||
| Profhilo프로파일로 · IBSA | Not found | Not found | On registerARTG 387132 | Not checked |
| On the Australian register. No Korean or US record found. Treatment page | ||||
| Restylane Vital / Restylane Skinboosters Vital레스틸렌 스킨부스터 바이탈 · Galderma | Approved수허12-703호 | Not found | On registerARTG 194004 | Not checked |
| Approved in Korea and on the Australian register. In Korea the lidocaine and Light versions are current; the plain version's permit expired on 1 October 2026. Treatment page | ||||
| Elravie Balance엘라비에 밸런스 · Humedix Co. Ltd | Approved제허15-362호 | Not found | Not checked | Not checked |
| Korean brand, approved in Korea. No US record found. Treatment page | ||||
Fat-dissolving injections
| Product | Korea (MFDS) | United States (FDA) | Australia (TGA) | Japan (PMDA) |
|---|---|---|---|---|
| V-OLET브이올렛주(데옥시콜산) · Daewoong Pharmaceutical | Approved품목기준코드 202105795 | Not found | Not checked | Not checked |
| Korean prescription drug (deoxycholic acid), approved for fat under the chin. Treatment page | ||||
| Kybella (Belkyra) for referenceKythera / Allergan | Not found | ApprovedNDA 206333 | On registerARTG 233201 | Not checked |
| Same active ingredient as V-OLET and Bellacolin. Approved in the US and Australia (as Belkyra); no Korean record found. Treatment page | ||||
| Bellacolin벨라콜린주(데옥시콜산) · LG Chem | Approved품목기준코드 202400198 | Not found | Not checked | Not checked |
| Korean prescription drug (deoxycholic acid), approved in 2024 for fat under the chin. Treatment page | ||||
Threads
| Product | Korea (MFDS) | United States (FDA) | Australia (TGA) | Japan (PMDA) |
|---|---|---|---|---|
| Silhouette Soft실루엣소프트 · Sinclair | Approved수허15-878호 | ClearedK142061 | On registerARTG 221747 | Not checked |
| Approved in Korea and on the Australian register. The US clearance is under the name Silhouette InstaLift. Treatment page | ||||
| Mint Lift민트리프팅 (MINT Lift) · HansBiomed Corp. | Approved제허14-1065호 | ClearedK220549 | On registerARTG 315417 | Not checked |
| Korean brand. Approved in Korea, cleared in the US and on the Australian register. Treatment page | ||||
Lifting and tightening devices
| Product | Korea (MFDS) | United States (FDA) | Australia (TGA) | Japan (PMDA) |
|---|---|---|---|---|
| Ultherapy (Ulthera System; original)울쎄라 · Merz | Approved수허09-1024호 | ClearedDEN080006 (De Novo 2009-09-11 | On registerARTG 225194 | Not found |
| Approved in Korea, cleared in the US and on the Australian register. No Japanese record found. Treatment page | ||||
| Ultherapy Prime울쎄라피 프라임 · Merz | Approved수허09-1024호 | ClearedK233996 | Not checked | Not found |
| Covered by the Ultherapy permit in Korea; cleared in the US on its own. Treatment page | ||||
| Thermage FLX써마지 FLX · Solta Medical | Approved수허18-245호 | ClearedK170758 | On registerARTG 302120 | Not found |
| Approved in Korea, cleared in the US and on the Australian register. No Japanese record found. Treatment page | ||||
| Shurink Universe (Ultraformer MPT)슈링크 유니버스 · Classys | Approved제허21-831호 | Not found | Not checked | Not found |
| Korean brand, approved in Korea; sold abroad as Ultraformer MPT. No US or Japanese record found. Treatment page | ||||
| Ultraformer III울트라포머 · Classys | Approved제허14-1422호 | Not found | Not checked | Not found |
| Korean brand, approved in Korea, where the same permit covers Shurink. No US record found. Treatment page | ||||
| Doublo (NEW DOUBLO 2.0)더블로 · Hironic | Approved제허22-587호 | ClearedK251334 | Not checked | Not found |
| Korean brand, approved in Korea. The US clearance covers its radiofrequency and plasma handpieces, not focused ultrasound. Treatment page | ||||
| Oligio올리지오 · Wontech | Approved제허20-396호 | ClearedK221989 | Not checked | Not found |
| Korean brand. Approved in Korea and cleared in the US, both as a general electrosurgical device for coagulating tissue. Treatment page | ||||
| Density덴서티 · Jeisys Medical | Approved제허23-472호 | ClearedK250065 | Not checked | Not found |
| Korean brand. Approved in Korea and cleared in the US, both as a general electrosurgical device for coagulating tissue. Treatment page | ||||
| Volnewmer볼뉴머 · Classys | Approved제허22-512호 | ClearedK240248 | Not checked | Not found |
| Korean brand. Approved in Korea and cleared in the US, both as a general electrosurgical device for coagulating tissue. Treatment page | ||||
| Morpheus8모피어스8 · InMode | Not found | ClearedK231790 | Not checked | Approved30700BZX00257000 |
| Cleared in the US and approved in Japan (as Morpheus Pro). No Korean record names it; InMode's Korean permit is for an RF platform. Treatment page | ||||
| Forma (InMode)포르마 · InMode | Not found | ClearedK210492 | Not checked | Not found |
| Cleared in the US for muscle aches and circulation. No Korean record names it. Treatment page | ||||
Lasers and microneedle RF
| Product | Korea (MFDS) | United States (FDA) | Australia (TGA) | Japan (PMDA) |
|---|---|---|---|---|
| Potenza포텐자 · Jeisys Medical Inc | Approved제허19-78호 | ClearedK231216 | On register394010 | Approved30500BZI00042000 |
| Korean brand. Approved in Korea, cleared in the US, on the Australian register, and approved in Japan (Potenza BASIC). Treatment page | ||||
| Sylfirm X실펌엑스 · Viol Co Ltd | Approved제허20-148호 | ClearedK213612 | On register404763 | Not found |
| Korean brand. Approved in Korea, cleared in the US and on the Australian register. Treatment page | ||||
| Secret RF시크릿 · Ilooda Co Ltd | Approved제허11-1071호 | ClearedK170325 | On register489105 | Certified305AGBZI00010000 |
| Korean brand. On the registers of all four; in Japan as a certified device. Treatment page | ||||
| PicoSure / PicoSure Pro피코슈어 · Cynosure LLC | Approved수허14-391호 | ClearedK261570 | Not checked | Approved30200BZX00153000 |
| Approved in Korea and Japan, cleared in the US. Treatment page | ||||
| PicoWay피코웨이 · Candela Corporation | Approved수허18-304호 | ClearedK220853 | Not checked | Approved23000BZX00270000 |
| Approved in Korea and Japan, cleared in the US. Treatment page | ||||
| Discovery Pico디스커버리 피코 · Quanta System SpA | Approved수허16-71호 | ClearedK240983 | Not checked | Approved30200BZI00018000 |
| Approved in Korea, cleared in the US. The Japanese approval covers Discovery Pico Plus. Treatment page | ||||
| PicoPlus피코플러스 · Lutronic | Approved제허15-1715호 | ClearedK173700 | Not checked | Not found |
| Korean brand. Approved in Korea, cleared in the US. Treatment page | ||||
| Helios (HELIOS III)헬리오스 · Laseroptek Co Ltd | Approved제허13-1491호 | ClearedK152856 | On register393512 | Not found |
| Korean brand. Approved in Korea, cleared in the US. The Australian entry is for the HELIOS 785 Pico model. Treatment page | ||||
| RevLite SI레블라이트 · Cynosure LLC | Approved수허14-888호 | ClearedK133254 | Not checked | Approved30500BZX00253000 |
| Approved in Korea and Japan, cleared in the US. Treatment page | ||||
| Fraxel (Fraxel Dual; newest model Fraxel FTX)프락셀 · Solta Medical | Approved수허10-500호 | ClearedK242142 | Not checked | Not found |
| Approved in Korea (Fraxel Dual, permit valid to 30 November 2026); the US clearance is for Fraxel FTX. Treatment page | ||||
| LUCAS Plus (clinics: 루카스 토닝)루카스 · AMT Engineering Co Ltd | Approved제허13-1691호 | ClearedK230340 | Not checked | Not found |
| Korean brand. Approved in Korea, cleared in the US. Treatment page | ||||
| Hollywood Spectra (Lutronic Spectra)스펙트라 · Lutronic | Approved제허26-401호 | ClearedK213569 | Not checked | Approved30800BZI00017000 |
| Korean brand. Approved in Korea and Japan, cleared in the US. Treatment page | ||||
How this was checked
Each cell comes from the register itself: 의약품안전나라 and the 의료기기 database for Korea, Drugs@FDA and the FDA device databases for the US, ARTG public summaries for Australia, and PMDA records for Japan. A maker’s statement that a product is approved somewhere was not counted. Where one name covers several models, the record and the model it names are in the CSV. For the Korean names clinics use, see Korean clinic names in English.