# K222710: IPL Cooling Hair Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.
- Decided: Dec 1, 2022 after 84 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: 22 generations back to K950019 (1995). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221001: IPL Home Use Hair Removal Device, Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. (2022) Summary page 4.

## Indications for use
IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.

Source page: https://510kreport.com/device/K222710
Methodology: https://510kreport.com/methodology