# K250183: CO2 Laser System (CO2 Laser SST-L23)

- Pathway: 510(k) (Traditional)
- Applicant: Zhuozhou Summer Star Technologies Co., Ltd.
- Decided: Apr 24, 2025 after 92 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: 9 generations back to K936109 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200042: CO2 Laser System, Beijing Superlaser Technology Co., Ltd. (2020) Summary page 6.
- K161925: CO2 Laser Therapy Machine, Beijing Adss Development Co., Ltd. (2016) Summary page 8.

## Indications for use
CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Source page: https://510kreport.com/device/K250183
Methodology: https://510kreport.com/methodology