# K232845: IPL Cooling Hair Removal Device

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Siken 3D Technology Development Co., Ltd.
- Decided: Nov 14, 2023 after 61 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)
- K230097: IPL Hair Removal Device, Model (s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108, Shenzhen Bsx Technology Electronics Co., Ltd. (2023) Summary page 5.

## 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/K232845
Methodology: https://510kreport.com/methodology