# K161926: ND YAG Q-switch Laser Therapy Machine

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Adss Development Co., Ltd.
- Decided: Feb 22, 2017 after 224 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 K943450 (1995). 239 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 245 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 6.

## Most influential descendants
- K232716: Q-Switched Nd:Yag laser (2023), 1 descendant of its own
- K193464: ND:YAG Laser (2020), 1 descendant of its own
- K260153: Q-Switched Nd: YAG Laser System (Glamor Q) (2026), 0 descendants of its own
- K250722: Nd: YAG Laser Therapy System (QN-1) (2025), 0 descendants of its own
- K231948: Mediyag (2024), 0 descendants of its own

## Indications for use
The ND YAG Q-switch Laser Therapy Machine 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/K161926
Methodology: https://510kreport.com/methodology