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 |