Silk'n Fx
510(k) K110301
Silk'n Fx 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) K110301 on 19 Aug 2011, 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 | NumberK110301 | Date19 Aug 2011 | StatusActive |
Official records
- FDA 510(k) database K110301
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- Withdrawn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 K110301
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 | |||
|---|---|---|---|---|
| PREMIER (AVOLOGI) Renelif | 7290106259218 / Renelif | 17290106259215 | — | On the market |
| Silk'n FaceFX 360 | 7290015764636 / FaceFX 360 | 17290015764633 | — | On the market |
| Silk'n FaceFX II | 7290015418614 / FaceFX II | 17290015418611 | — | On the market |
| SISLOY Supreme | 866057000314 / Supreme | 10866057000311 | — | On the market |
Similar devices
Other devices filed under FDA product code OHS (Light Based Over The Counter Wrinkle Reduction).
- Perfectio LED infrared device by Omm Imports, Inc. D/B/A Zero Gravity
- KALA MINI 2.0 (KALA-04) by Shenzhen Kaiyan Medical Equipment Co., Ltd
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- LED LIGHT MASK (A093) by Foshan Guangyu Weilai Medical Equipment Co., Ltd.
- HIGHERDOSE Body Sculptor (Model: GS-03) by Shenzhen Kaiyan Medical Equipment Co., Ltd
- QUASAR C100, BABY QUASAR PLUS, QUASAR MD PLUS; WRINKLE REDUCTION DEVICE by Silverbay, LLC, D/B/A Quasar Bio-Tech
- LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) by Shenzhen Idea Light Limited