Silk'n Infinity
510(k) K171433
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171433 | Date11 Aug 2017 | StatusActive |
Official records
- FDA 510(k) database K171433
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OHT
- 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
Overview
AI-generated summary, 26 Sep 2026
The Silk'n Infinity is a light-based over-the-counter hair removal device. It is substantially equivalent to predicate devices and classified under device class 2 with product code OHT.
It is supplied as a reusable system for home use, authorized via FDA 510(k) clearance (K171433) under regulation number 878.4810. The device is intended for general and plastic surgery-related aesthetic applications and is manufactured by Home Skinovations, Ltd.
Devices cleared under K171433
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 7 | 7290019840244 / Silk'n 7 | 17290019840241 | — | On the market |
| Silk'n 7 | 7290019840251 / Silk'n 7 | 17290019840258 | — | On the market |
| Silk'n Infinity | 7290015764759 / Infinity | 17290015764756 | — | On the market |
| Silk'n Infinity Fast | 7290019840022 / Infinity Fast | 17290019840029 | — | On the market |
Similar devices
Other devices filed under FDA product code OHT (Light Based Over-The-Counter Hair Removal).
- IPL Cooling Hair Removal Device by Shenzhen Siken 3D Technology Development Co., Ltd.
- Home Use IPL Beauty Device by Shenzhen Mismon Technology Co., Ltd.
- Intense Pulse Light Therapeutic Apparatus by Shenzhen Greatro Electronic Technology Co., Ltd.
- Beurer IPL 8500 device/ IPL VelvetSkin Pro by Home Well Trading, Ltd.
- Superior Hair Remover by Guangzhou Haoxingwan Technology Co., Ltd.
- SmoothSkin BARE+ by CYDEN LIMITED
- Light based hair removal device by Shenzhen GSD Tech Co., Ltd.
- Braun Silk.expert Mini by CYDEN LIMITED
- Hair Removal Device, Model(s): R2815-G Pro, R2815-G by Shenzhen Jianchao Intelligent Technology Co., Ltd.
- IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 by Shenzhen Bosidin Technology Co., Ltd.