Leaf Smooth
by Shenzhen Leaflife Technology Co., Ltd.
510(k) K212697
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212697 | Date19 Nov 2021 | StatusActive |
Official records
- FDA 510(k) database K212697
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OHT
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Leaf Smooth is a light-based, over-the-counter hair removal device. It is designed to facilitate the removal of unwanted hair using light-based technology.
This device is classified as a Class 2 medical device under regulation number 878.4810. It has received FDA 510(k) clearance.
Devices cleared under K212697
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 | |||
|---|---|---|---|---|
| Leaf life LH-LIPLB | LH-LIPLB | 06974223650028 | — | On the market |
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