CO2 Laser System, Model C-Las
510(k) K063698
CO2 Laser System, Model C-Las is a medical device (FDA Class II; FDA product code GEX, Powered Laser Surgical Instrument) made by Clinicon Corp., cleared under FDA 510(k) K063698 on 2 Mar 2007, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063698 | Date2 Mar 2007 | StatusActive |
Official records
- FDA 510(k) database K063698
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
- xeo+ Family by CUTERA, INC.
- MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES by Medart A/S
- Bare Fiber IR-Q 600 2942 by Asclepion Laser Technologies GmbH
- ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT PROCEDURE KIT by ANGIODYNAMICS, INC.
- ACCUTRAC by Boston Scientific
- DEKA MOTUS AX by El.En Electronic Engineering Spa
- POLARIS, GYNECOLOGY INDICATIONS by Pfizer Laser Systems
- OPTICA 120 ND:YAG SURGICAL LASER SYSTEM by XINTEC CORPORATION
- SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS by Sharplan Lasers, Inc.
- LUMINA 24 by Rogers Sciences, Inc.