# K252519: CO2 Laser Therapy System (K106)

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Keylaser Sci-Tech Co.,Ltd
- Decided: Nov 7, 2025 after 88 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.
No later device cites it as a predicate yet.
0 of 20 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 6.

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

Source page: https://510kreport.com/device/K252519
Methodology: https://510kreport.com/methodology