# K212897: IPL Hair Removal Device, model: AI01

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Century Dongyuan Technology CO, Ltd.
- Decided: Nov 4, 2021 after 55 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). 53 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183217: IPL Hair Removal Device, Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K221466: IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 (2022), 0 descendants of its own

## Indications for use
The IPL Hair Removal Device (Model: AIO1) is intended for the removal of unwanted body hair.

Source page: https://510kreport.com/device/K212897
Methodology: https://510kreport.com/methodology