The following data is part of a premarket notification filed by Laserscope with the FDA for Orion Series Surgical Laser System (q-switched Nd:yag Configuration).
| Device ID | K964818 |
| 510k Number | K964818 |
| Device Name: | ORION SERIES SURGICAL LASER SYSTEM (Q-SWITCHED ND:YAG CONFIGURATION) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Contact | Lisa Mcgrath |
| Correspondent | Lisa Mcgrath LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-06-17 |
| Summary: | summary |