# K193464: ND:YAG Laser

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Superlaser Technology Co., Ltd.
- Decided: Apr 13, 2020 after 119 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 4.

## Most influential descendants
- K260153: Q-Switched Nd: YAG Laser System (Glamor Q) (2026), 0 descendants of its own

## Indications for use
The 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/K193464
Methodology: https://510kreport.com/methodology