The following data is part of a premarket notification filed by Laserscope with the FDA for Laserscope Omni Plus Photosurgical System.
| Device ID | K854027 |
| 510k Number | K854027 |
| Device Name: | LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM |
| Classification | Laser For Gastro-urology Use |
| Applicant | LASERSCOPE 3350 SCOTT BLVD., BLDG.30 Santa Clara, CA 95051 |
| Contact | Ross Erickson |
| Correspondent | Ross Erickson LASERSCOPE 3350 SCOTT BLVD., BLDG.30 Santa Clara, CA 95051 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-01 |
| Decision Date | 1985-12-02 |