The following data is part of a premarket notification filed by Sorenson Laboratories, Inc. with the FDA for Handi-lase Co2 Surgical Laser Instrument.
| Device ID | K920597 |
| 510k Number | K920597 |
| Device Name: | HANDI-LASE CO2 SURGICAL LASER INSTRUMENT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SORENSON LABORATORIES, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose SORENSON LABORATORIES, INC. 1963 ROCK ST. SUITE 17 Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1992-06-04 |