# K232274: IPL hair removal device

- Pathway: 510(k) (Traditional)
- Applicant: Lumenessa Corp
- Decided: Sep 28, 2023 after 59 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: 18 generations back to K950019 (1995). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160968: iPulse SmoothSkin Gold Hair Removal Device, Cyden Limited (2016) Summary page 5.
- K161428: PerfectSmooth, Shen Zhen Cosbeauty Co., Ltd. (2017) Summary page 6.

## Indications for use
The product is an over-the-counter device intended for removal of unwanted body and facial hair.

Source page: https://510kreport.com/device/K232274
Methodology: https://510kreport.com/methodology