The following data is part of a premarket notification filed by Surgilase, Inc. with the FDA for Model Sl45 Surgilase Co2 Surgical Laser Systems.
| Device ID | K884313 |
| 510k Number | K884313 |
| Device Name: | MODEL SL45 SURGILASE CO2 SURGICAL LASER SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick, RI 02866 |
| Contact | Timothy J Shea |
| Correspondent | Timothy J Shea SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick, RI 02866 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-13 |
| Decision Date | 1988-10-27 |