The following data is part of a premarket notification filed by Laserscope with the FDA for Aura Laser System.
| Device ID | K951034 |
| 510k Number | K951034 |
| Device Name: | AURA LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERSCOPE 3052 ORCHARD DR. San Jose, CA 95134 -2011 |
| Contact | Pricilla Beggs |
| Correspondent | Pricilla Beggs 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 | 1995-03-06 |
| Decision Date | 1995-04-13 |