Silk'n BellaVisage
Silk'n BellaVisage (7290112450227) is a Class II device made by Home Skinovations, Ltd., cleared under FDA 510(k) K162784 on 25 Mar 2017 and listed in FDA GUDID since 18 Oct 2018 (UDI-DI 17290112450224), 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 | Number17290112450224 | Date18 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK162784 | Date25 Mar 2017 | StatusActive |
Official records
- AccessGUDID record 17290112450224
- FDA 510(k) database K162784
Across registries
- FDA 510(k) K162784 decided 25 Mar 2017 Active
- FDA GUDID UDI-DI 17290112450224 listed 18 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K162784
- Listed FDA GUDID 17290112450224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Silk'n
- Generic name
- Radio-frequency skin surface treatment system
- Model / Ref / Catalog
- BellaVisage, 7290112450227
- Primary DI / UDI-DI
- 17290112450224
- 510(k) Number
- FDA product code
- OHS, PAY
- GMDN term
- Radio-frequency skin surface treatment system
- Device class
- Class II
- Regulation number
- 878.4810, 878.4420
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Radio-frequency skin surface treatment system.