The following data is part of a premarket notification filed by Premier Laser Systems, Inc. with the FDA for Pegasus Nd:yag Laser System.
| Device ID | K980559 |
| 510k Number | K980559 |
| Device Name: | PEGASUS ND:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PREMIER LASER SYSTEMS, INC. 3 MORGAN Irvine, CA 92718 |
| Contact | Marcia Van Valen |
| Correspondent | Marcia Van Valen 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 | 1998-02-13 |
| Decision Date | 1998-08-24 |