# K230090: Diode Laser Hair Removal

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Lotuxs Technology Co., Ltd.
- Decided: Apr 19, 2023 after 97 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: 12 generations back to K950019 (1995). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142845: SILKPRO laser hair removal system, Wuhan Lotuxs Technology Co., Ltd. (2015) Summary page 4.

## Indications for use
Diode Laser Hair Removal is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. Diode Laser Hair Removal is also intended for permanent reduction in hair regrowth defined as a 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/K230090
Methodology: https://510kreport.com/methodology