# K250465: CO2 Laser Machine (Lume)

- Pathway: 510(k) (Traditional)
- Applicant: Nanjing Bestview Laser S&T Co., Ltd.
- Decided: Jun 9, 2025 after 111 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: 21 generations back to K943450 (1995). 358 ancestors in all.
No later device cites it as a predicate yet.
0 of 359 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201109: CO2 Laser Therapy System, Shanghai Apolo Medical Technology Co., Ltd. (2020) Summary page 6.
- K162169: EdgeOne CO2 Laser, Jeisys Medical, Inc. (2016) Summary page 6.

## Indications for use
The CO2 Laser Machine (Lume) is used for body soft tissue vaporization and coagulation in dermatology and plastic surgery, general surgery, gynecology.

Source page: https://510kreport.com/device/K250465
Methodology: https://510kreport.com/methodology