# K222432: IPL Hair Removal Device, Model (s): KCA423,  KCA437, KCA439

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Guangye Biotechnology Co., Ltd.
- Decided: Oct 11, 2022 after 60 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: 19 generations back to K950019 (1995). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181568: IPL Salon Hair Reduction System, Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt (2018) Summary page 4.

## Indications for use
IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K222432
Methodology: https://510kreport.com/methodology