Silk'n Blue
Silk'n Blue (7290015418621) is a cosmetic red-light phototherapy system (FDA Class II; FDA product code OLP, Over-The-Counter Powered Light Based Laser For Acne) made by Home Skinovations, Ltd., cleared under FDA 510(k) K121435 on 22 Feb 2013 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI 17290015418628), 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 | Number17290015418628 | Date15 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK121435 | Date22 Feb 2013 | StatusActive |
Official records
- AccessGUDID record 17290015418628
- FDA 510(k) database K121435
Across registries
- FDA 510(k) K121435 decided 22 Feb 2013 Active
- FDA GUDID UDI-DI 17290015418628 listed 15 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K121435
- Listed FDA GUDID 17290015418628
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- Withdrawn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
- Blue, 7290015418621
- Primary DI / UDI-DI
- 17290015418628
- 510(k) Number
- FDA product code
- OLP
- 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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Other devices filed under FDA product code OLP (Over-The-Counter Powered Light Based Laser For Acne).
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