# K192516: Diode Laser 808nm

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Superlaser Technology Co., Ltd.
- Decided: Dec 10, 2019 after 88 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). 86 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181019: Diode Laser System, Guangzhou Huafei Tongda Technology Co., Ltd. (2018) Summary page 7.
- K180353: Diode laser hair removal device, Zhengzhou PZ Laser Slim Technology Co., Ltd. (2018) Summary page 7.

## Most influential descendants
- K193328: IPL + Diode Laser Machine (2020), 0 descendants of its own

## Indications for use
The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), 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/K192516
Methodology: https://510kreport.com/methodology