# K221635: IPL sapphire ice cooling hair remove device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Desida Technology Co., Ltd.
- Decided: Aug 31, 2022 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: 22 generations back to K950019 (1995). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210311: Home Use IPL Beauty Device, Model (s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7., Shenzhen Mismon Technology Co., Ltd. (2021) Summary page 4.
- K161565: DUO, Stetic Medical Aesthetics Development (Shenzhen) Co.,Ltd (2016) Summary page 4.
- K221001: IPL Home Use Hair Removal Device, Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. (2022) Summary page 5.

## Indications for use
IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

Source page: https://510kreport.com/device/K221635
Methodology: https://510kreport.com/methodology