The following data is part of a premarket notification filed by Medart Corp. with the FDA for Uni-laser 450p Co2 Laser System & Accessories.
| Device ID | K991297 |
| 510k Number | K991297 |
| Device Name: | UNI-LASER 450P CO2 LASER SYSTEM & ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MEDART CORP. 11772 SORRENTO VALLEY RD. #234 San Diego, CA 92121 |
| Contact | Marilyn M Chou |
| Correspondent | Marilyn M Chou MEDART CORP. 11772 SORRENTO VALLEY RD. #234 San Diego, CA 92121 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-15 |
| Decision Date | 1999-07-12 |