The following data is part of a premarket notification filed by Reliant Technologies, Inc. with the FDA for Unica 315 M Co2 Surgical Laser System.
| Device ID | K971821 |
| 510k Number | K971821 |
| Device Name: | UNICA 315 M CO2 SURGICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RELIANT TECHNOLOGIES, INC. 1000 BURNETT AVE., SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf RELIANT TECHNOLOGIES, INC. 1000 BURNETT AVE., SUITE 450 Concord, CA 94520 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-16 |
| Decision Date | 1997-09-25 |
| Summary: | summary |