# K192735: Diode Laser Hair Removal Machine

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Lead Beauty S & T Co., Ltd.
- Decided: Apr 3, 2020 after 189 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 15 generations back to K910422 (1992). 63 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180353: Diode laser hair removal device, Zhengzhou PZ Laser Slim Technology Co., Ltd. (2018) Summary page 5.

## Most influential descendants
- K242951: Diode laser hair removal machine (QDTM-02) (2025), 1 descendant of its own
- K261693: Diode laser hair removal machine (QDTM-04) (2026), 0 descendants of its own

## Indications for use
The Diode Laser Hair Removal Machine is intended for hair removal permanent hair reduction on all skin types (Fitzpatrick skin type IVI), including tanned skin. Permanent hair reduction is 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/K192735
Methodology: https://510kreport.com/methodology