The following data is part of a premarket notification filed by Laser Photonics, Inc. with the FDA for Rqm-1005 Integulaser Ruby Medical Laser System.
| Device ID | K933140 |
| 510k Number | K933140 |
| Device Name: | RQM-1005 INTEGULASER RUBY MEDICAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER PHOTONICS, INC. 12351 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Clement Darrow |
| Correspondent | Clement Darrow LASER PHOTONICS, INC. 12351 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-28 |
| Decision Date | 1994-03-02 |