Silk'n FaceFX 360
Silk'n FaceFX 360 (7290015764636) is a cosmetic red-light phototherapy system (FDA Class II; FDA product code OHS, Light Based Over The Counter Wrinkle Reduction) made by Home Skinovations, Ltd., cleared under FDA 510(k) K110301 on 19 Aug 2011 and listed in FDA GUDID since 19 Dec 2018 (UDI-DI 17290015764633), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number17290015764633 | Date19 Dec 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110301 | Date19 Aug 2011 | StatusActive |
Official records
- AccessGUDID record 17290015764633
- FDA 510(k) database K110301
Across registries
- FDA 510(k) K110301 decided 19 Aug 2011 Active
- FDA GUDID UDI-DI 17290015764633 listed 19 Dec 2018 Listed
Timeline
- Cleared FDA 510(k) K110301
- Listed FDA GUDID 17290015764633
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Silk'n
- Generic name
- Cosmetic red-light phototherapy system, home-use
- Model / Ref / Catalog
- FaceFX 360, 7290015764636
- Primary DI / UDI-DI
- 17290015764633
- 510(k) Number
- FDA product code
- OHS
- GMDN term
- Cosmetic red-light phototherapy system, home-use
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
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