# K182924: Diode Laser Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Weifang KM Electronics Co., Ltd.
- Decided: Apr 15, 2019 after 178 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: 14 generations back to K910422 (1992). 62 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161692: Diode Laser Therapy Machine, Beijing Adss Development Co., Ltd. (2016) Summary page 4.
- K141973: Diode Laser Hair Removal System, Beijing Anchorfree Technology Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K210033: Laser Treatment System, Model: NYX and Grace (2021), 1 descendant of its own
- K212793: Laser Treatment System, Model: Hera, Armo (2021), 0 descendants of its own

## Indications for use
The Diode Laser Treatment System 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/K182924
Methodology: https://510kreport.com/methodology