The following data is part of a premarket notification filed by Premier Laser Systems, Inc. with the FDA for Aurora Diode Laser System.
| Device ID | K974586 |
| 510k Number | K974586 |
| Device Name: | AURORA DIODE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PREMIER LASER SYSTEMS, INC. 3 MORGAN Irvine, CA 92718 |
| Contact | Lisa Mojica |
| Correspondent | Lisa Mojica PREMIER LASER SYSTEMS, INC. 3 MORGAN Irvine, CA 92718 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-09 |
| Decision Date | 1998-07-15 |