The following data is part of a premarket notification filed by Lares Research, Inc. with the FDA for Lares Research Sunlase 800p Laser System (to Be Sold As Peiolase For Laserenap).
| Device ID | K983524 |
| 510k Number | K983524 |
| Device Name: | LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LARES RESEARCH, INC. 295 LOCKHEED AVE. Chico, CA 95973 |
| Contact | Thomas H Louisell |
| Correspondent | Thomas H Louisell LARES RESEARCH, INC. 295 LOCKHEED AVE. Chico, CA 95973 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-08 |
| Decision Date | 1999-04-01 |