The following data is part of a premarket notification filed by Laserscope with the FDA for 800 Series Surgical Laser System Orion Series Surgical Laser System Angled Delivery Devices.
| Device ID | K972575 |
| 510k Number | K972575 |
| Device Name: | 800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES |
| 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 | 1997-07-10 |
| Decision Date | 1998-07-17 |
| Summary: | summary |