The following data is part of a premarket notification filed by Clarus Medical, Llc. with the FDA for Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160.
| Device ID | K021848 |
| 510k Number | K021848 |
| Device Name: | CLARUS STRAIGHT FIRING LASER FIBER; CLARUS SIDE FIRING LASER FIBER; MODELS 1150, 1160 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH Minneapolis, MN 55427 |
| Contact | Tom Barthel |
| Correspondent | Tom Barthel CLARUS MEDICAL, LLC. 1000 BOONE AVE. NORTH Minneapolis, MN 55427 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-05 |
| Decision Date | 2002-09-03 |
| Summary: | summary |