SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM

Powered Laser Surgical Instrument

TISSUE MEDICAL LASERS, INC.

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.

Pre-market Notification Details

Device IDK000317
510k NumberK000317
Device Name:SPECTRA-VRM Q-SWITCHED ND:YAG LASER SYSTEM, SPECTRA-VRM
ClassificationPowered Laser Surgical Instrument
Applicant TISSUE MEDICAL LASERS, INC. 4432 ANAHEIM AVE., N.E. Albuquerque,  NM  87113
ContactDwight Zurawski
CorrespondentDwight Zurawski
TISSUE MEDICAL LASERS, INC. 4432 ANAHEIM AVE., N.E. Albuquerque,  NM  87113
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-01
Decision Date2000-10-27

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