Silk'n FaceFX II
Silk'n FaceFX II (7290015418614) 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 13 Dec 2016 (UDI-DI 17290015418611), 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 | Number17290015418611 | Date13 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110301 | Date19 Aug 2011 | StatusActive |
Official records
- AccessGUDID record 17290015418611
- FDA 510(k) database K110301
Across registries
- FDA 510(k) K110301 decided 19 Aug 2011 Active
- FDA GUDID UDI-DI 17290015418611 listed 13 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K110301
- Listed FDA GUDID 17290015418611
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- Withdrawn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 II, 7290015418614
- Primary DI / UDI-DI
- 17290015418611
- 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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