# K212697: Leaf Smooth

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Leaflife Technology Co., Ltd.
- Decided: Nov 19, 2021 after 86 days
- Product code: OHT (Light Based Over-The-Counter Hair Removal)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K950019 (1995). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192432: IPL Home Use Hair Removal Device Model (s): D-1128, D-1103, D-1119, D-1129, D-1130, Shenzhen Bosidin Technology Co., Ltd. (2019) Summary page 5.
- K181568: IPL Salon Hair Reduction System, Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt (2018) Summary page 5.
- K160968: iPulse SmoothSkin Gold Hair Removal Device, Cyden Limited (2016) Summary page 5.

## Indications for use
The Leaf Smooth is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Source page: https://510kreport.com/device/K212697
Methodology: https://510kreport.com/methodology