Silk'n Titan Allways
510(k) K230013
Silk'n Titan Allways is a medical device (FDA Class II; FDA product code PAY, Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction) made by Silkn Beauty Ltd., cleared under FDA 510(k) K230013 on 30 Aug 2023, 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 | NumberK230013 | Date30 Aug 2023 | StatusActive |
Official records
- FDA 510(k) database K230013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PAY
- FDA applicant
- Silk'N Beauty , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4420
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K230013
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 Titan AllWays | 7290019840008 / Titan AllWays | 17290019840005 | — | On the market |
| Silk'n Titan Mini | 7290019840220 / Titan Mini | 17290019840227 | — | On the market |
| Silk'n Titan MultiPlatform | 7290019840237 / Titan MultiPlatform | 17290019840234 | — | On the market |
Similar devices
Other devices filed under FDA product code PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction).