The following data is part of a premarket notification filed by Laser Peripherals Llc. with the FDA for Laser Peripherals Inc. Bare Fiber.
| Device ID | K961516 |
| 510k Number | K961516 |
| Device Name: | LASER PERIPHERALS INC. BARE FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER PERIPHERALS LLC. 5484 FELTL RD. Minnetonka, MN 55343 |
| Contact | Nancy L Arnold |
| Correspondent | Nancy L Arnold LASER PERIPHERALS LLC. 5484 FELTL RD. Minnetonka, MN 55343 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-22 |
| Decision Date | 1996-06-27 |