The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Clinicon Waveguide Platform With Interconnect For Luxar Accessories.
| Device ID | K014236 |
| 510k Number | K014236 |
| Device Name: | CLINICON WAVEGUIDE PLATFORM WITH INTERCONNECT FOR LUXAR ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLINICON CORP. 16787 BERNARDO CENTER DR. SUITE A San Diego, CA 92128 |
| Contact | Sean M Curry |
| Correspondent | Sean M Curry 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 | 2001-12-26 |
| Decision Date | 2002-03-26 |
| Summary: | summary |