MLT 20

Powered Laser Surgical Instrument

MEDICAL LASER TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Medical Laser Technology, Inc. with the FDA for Mlt 20.

Pre-market Notification Details

Device IDK953800
510k NumberK953800
Device Name:MLT 20
ClassificationPowered Laser Surgical Instrument
Applicant MEDICAL LASER TECHNOLOGY, INC. 2104-A MOON STATION DR. Kennesaw,  GA  30144
ContactJames E Bishop
CorrespondentJames E Bishop
MEDICAL LASER TECHNOLOGY, INC. 2104-A MOON STATION DR. Kennesaw,  GA  30144
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-14
Decision Date1995-11-29

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