The following data is part of a premarket notification filed by Laserscope with the FDA for Omniplus Photosurgical Laser System For Ob-gyn.
| Device ID | K863221 |
| 510k Number | K863221 |
| Device Name: | OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN |
| Classification | Laser, Surgical, Gynecologic |
| 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 | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-21 |
| Decision Date | 1987-03-02 |