The following data is part of a premarket notification filed by Minnesota Laser Corp. with the FDA for For Use In General & Plastic Surgery & Dermatology.
| Device ID | K852696 |
| 510k Number | K852696 |
| Device Name: | FOR USE IN GENERAL & PLASTIC SURGERY & DERMATOLOGY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | MINNESOTA LASER CORP. 6470 RIVERVIEW TERRACE N.E. Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MINNESOTA LASER CORP. 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 | 1985-06-26 |
| Decision Date | 1985-09-19 |