# K063698: CO2 Laser System, Model C-Las

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Mar 2, 2007 after 79 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: 1 generation back to K875338 (1988). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K875338: Chrys (TM) Model Med-Max, California Laboratories, Inc. (1988) Summary page 1.

## Most influential descendants
- K093251: Omniguide Beampath Fels 25A CO2 Laser System (2009), 3 descendants of its own
- K140378: Flexguide Ultra Beampath Robotic Fiber Conduit (2014), 2 descendants of its own
- K170777: Bovie J-Plasma Precise FLEX Handpiece (2017), 1 descendant of its own
- K202880: J-Plasma Precise FLEX Handpiece (2021), 0 descendants of its own

## Indications for use
The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties: Cosmetic Surgery Dermatology General Surgery Gynecology Head & Neck Surgery Neurosurgery Oral Surgery Orthopedic Surgery Otorhinolaryngology Pediatric Surgery Plastic & Reconstructive Surgery Podiatry Urology

Source page: https://510kreport.com/device/K063698
Methodology: https://510kreport.com/methodology