Silk'n HST
510(k) K162784
Silk'n HST is a medical device (FDA Class II; FDA product code OHS, Light Based Over The Counter Wrinkle Reduction) made by Home Skinovations, Ltd., cleared under FDA 510(k) K162784 on 25 Mar 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162784 | Date25 Mar 2017 | StatusActive |
Official records
- FDA 510(k) database K162784
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OHS
- FDA applicant
- Home Skinovations , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K162784
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Silk'n BellaVisage | 7290112450227 / BellaVisage | 17290112450224 | — | On the market |
| Silk'n BellaVisage Hybrid | 7290019840039 / BellaVisage Hybrid | 17290019840036 | — | On the market |
| Silk'n BellaVisage Hybrid | 7290112452016 / BellaVisage Hybrid | 17290112452013 | — | On the market |
| Silk'n Titan | 7290015763851 / Titan | 17290015763858 | — | On the market |
| Silk'n Titan AllWays | 7290112451552 / Titan AllWays | 17290112451559 | — | On the market |
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