The following data is part of a premarket notification filed by Laserscope with the FDA for Omniplus Freq Double Nd:yag Photosurg Sys/neuro.
| Device ID | K862514 |
| 510k Number | K862514 |
| Device Name: | OMNIPLUS FREQ DOUBLE ND:YAG PHOTOSURG SYS/NEURO |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1987-02-04 |