The following data is part of a premarket notification filed by Surgilase, Inc. with the FDA for Surgilase/op 15, 20, 25, 30, 40, 50 Co2 Surg. Lase.
| Device ID | K932421 |
| 510k Number | K932421 |
| Device Name: | SURGILASE/OP 15, 20, 25, 30, 40, 50 CO2 SURG. LASE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGILASE, INC. I-95 CORPORATE PARK 33 PLAN WAY Warwick, RI 02866 |
| Contact | John D Bonasera |
| Correspondent | John D Bonasera 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 | 1993-05-19 |
| Decision Date | 1993-10-15 |