The following data is part of a premarket notification filed by Mnlase, Inc. with the FDA for Dl100 C02 Surgical Laser System.
| Device ID | K915085 |
| 510k Number | K915085 |
| Device Name: | DL100 C02 SURGICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MNLASE, INC. C/O C.G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MNLASE, INC. C/O C.G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-12 |
| Decision Date | 1992-02-28 |