# K192528: CO2 Laser Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Shangdong Huamei Technology Co., Ltd.
- Decided: Dec 3, 2019 after 81 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: 7 generations back to K936109 (1994). 19 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161925: CO2 Laser Therapy Machine, Beijing Adss Development Co., Ltd. (2016) Summary page 5.

## Most influential descendants
- K200042: CO2 Laser System (2020), 5 descendants of its own
- K262269: CO2 Laser System (MBT- CO2 Laser) (2026), 0 descendants of its own
- K260257: CO2 Laser System (2026), 0 descendants of its own
- K253920: CO2 Laser Treatment Machine (CFR3M1) (2026), 0 descendants of its own
- K250183: CO2 Laser System (CO2 Laser SST-L23) (2025), 0 descendants of its own

## Indications for use
The CO2 Laser Therapy System 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/K192528
Methodology: https://510kreport.com/methodology