SURGICAL LASER MICRO-TIPS

Powered Laser Surgical Instrument

SURGICAL LASER TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Surgical Laser Micro-tips.

Pre-market Notification Details

Device IDK844644
510k NumberK844644
Device Name:SURGICAL LASER MICRO-TIPS
ClassificationPowered Laser Surgical Instrument
Applicant SURGICAL LASER TECHNOLOGIES, INC. 933 COLLINS RD. Villa Hills,  KY  41017
ContactRichard L Studer
CorrespondentRichard L Studer
SURGICAL LASER TECHNOLOGIES, INC. 933 COLLINS RD. Villa Hills,  KY  41017
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-11-28
Decision Date1985-05-10

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