# K131837: CO2 Fractional Laser

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Honkon Technologies Co., Ltd.
- Decided: Jan 22, 2014 after 216 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: 13 generations back to K910422 (1992). 151 ancestors in all.
No later device cites it as a predicate yet.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080496: Mosaic ECO2 Laser System, Lutronic Corporation (2008) Summary page 1.

## Indications for use
The C02 Laser (lO600nm) is indicated for use in dermatology procedures requiring ablation, resurfacing and coagulation of soft tissue.

Source page: https://510kreport.com/device/K131837
Methodology: https://510kreport.com/methodology