Silk'n 7
by Silkn Beauty Ltd. 2 variants
Silk'n 7 (7290019840251) is a cosmetic red-light phototherapy system (FDA Class II) made by Silkn Beauty Ltd., cleared under FDA 510(k) K171433 on 11 Aug 2017 and listed in FDA GUDID since 30 Jan 2024 (UDI-DI 17290019840258), 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 | Number17290019840258 | Date30 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171433 | Date11 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 17290019840258
- FDA 510(k) database K171433
Across registries
- FDA 510(k) K171433 decided 11 Aug 2017 Active
- FDA GUDID UDI-DI 17290019840258 listed 30 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K171433
- Listed FDA GUDID 17290019840258
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- Withdrawn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
- Silk'n 7, 7290019840251
- Primary DI / UDI-DI
- 17290019840258
- 510(k) Number
- FDA product code
- NFO, ONF, OHT
- GMDN term
- Cosmetic red-light phototherapy system, home-use
- Device class
- Class II
- Regulation number
- 882.5890, 878.4810
- GUDID distribution status
- In Commercial Distribution
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