The following data is part of a premarket notification filed by Laserscope with the FDA for Laserscope Omniplus Photosurgical Syst/nd:yag Otol.
| Device ID | K855146 |
| 510k Number | K855146 |
| Device Name: | LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL |
| Classification | Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology |
| 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 | LMS |
| CFR Regulation Number | 874.4490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-24 |
| Decision Date | 1986-04-11 |