# K161925: CO2 Laser Therapy Machine

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Adss Development Co., Ltd.
- Decided: Oct 5, 2016 after 84 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: 6 generations back to K936109 (1994). 18 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110434: Trixel CO2 Laser, Beijing Syntech Laser CO., LTD. (2011) Summary page 7.

## Most influential descendants
- K192528: CO2 Laser Therapy System (2019), 8 descendants of its own
- K200042: CO2 Laser System (2020), 5 descendants of its own
- K162398: CO2 Laser Therapy Systems (2017), 2 descendants of its own
- K191518: CO2 Laser System (2019), 1 descendant of its own
- K262269: CO2 Laser System (MBT- CO2 Laser) (2026), 0 descendants of its own

## Indications for use
The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Source page: https://510kreport.com/device/K161925
Methodology: https://510kreport.com/methodology