LASERMATIC COMBOLASER MODEL 5050

Powered Laser Surgical Instrument

LASERMATIC OY

The following data is part of a premarket notification filed by Lasermatic Oy with the FDA for Lasermatic Combolaser Model 5050.

Pre-market Notification Details

Device IDK895279
510k NumberK895279
Device Name:LASERMATIC COMBOLASER MODEL 5050
ClassificationPowered Laser Surgical Instrument
Applicant LASERMATIC OY 45 WEST ST. SUITE 2 North Attleboro,  MA  02760
ContactFuller W Morton
CorrespondentFuller W Morton
LASERMATIC OY 45 WEST ST. SUITE 2 North Attleboro,  MA  02760
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-24
Decision Date1989-11-08

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