# K232716: Q-Switched Nd:Yag laser

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Zhemai Technology Co., Ltd.
- Decided: Nov 30, 2023 after 86 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: 16 generations back to K943450 (1995). 240 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161926: ND YAG Q-switch Laser Therapy Machine, Beijing Adss Development Co., Ltd. (2017) Summary page 7.

## Most influential descendants
- K250722: Nd: YAG Laser Therapy System (QN-1) (2025), 0 descendants of its own

## Indications for use
The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

Source page: https://510kreport.com/device/K232716
Methodology: https://510kreport.com/methodology