The following data is part of a premarket notification filed by Laserscope with the FDA for Laserscope Omniplus Photosurgical System For (ent).
| Device ID | K864975 |
| 510k Number | K864975 |
| Device Name: | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT) |
| Classification | Laser, Ent Microsurgical Carbon-dioxide |
| Applicant | LASERSCOPE 3350 SCOTT BLVD., BLDG.30 Santa Clara, CA 95051 |
| Contact | Richard P Rudy |
| Correspondent | Richard P Rudy LASERSCOPE 3350 SCOTT BLVD., BLDG.30 Santa Clara, CA 95051 |
| Product Code | EWG |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-22 |
| Decision Date | 1987-02-25 |