The following data is part of a premarket notification filed by Tissue Medical Lasers, Inc. with the FDA for Spectra-vrm Q-switched Nd:yag Laser System, Spectra-vrm.
| Device ID | K000317 |
| 510k Number | K000317 |
| Device Name: | SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TISSUE MEDICAL LASERS, INC. 4432 ANAHEIM AVE., N.E. Albuquerque, NM 87113 |
| Contact | Dwight Zurawski |
| Correspondent | Dwight Zurawski TISSUE MEDICAL LASERS, INC. 4432 ANAHEIM AVE., N.E. Albuquerque, NM 87113 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-01 |
| Decision Date | 2000-10-27 |