The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Co2 Laser System, Model C-las.
| Device ID | K063698 |
| 510k Number | K063698 |
| Device Name: | CO2 LASER SYSTEM, MODEL C-LAS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLINICON CORP. 16787 BERNARDO CENTER DR. SUITE A San Diego, CA 92128 |
| Contact | Kim Bloom |
| Correspondent | Kim Bloom CLINICON CORP. 16787 BERNARDO CENTER DR. SUITE A San Diego, CA 92128 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-13 |
| Decision Date | 2007-03-02 |
| Summary: | summary |