PARADERM -585M DERMATOLOGICAL LASER

Powered Laser Surgical Instrument

PARADIGM LASERS, INC.

The following data is part of a premarket notification filed by Paradigm Lasers, Inc. with the FDA for Paraderm -585m Dermatological Laser.

Pre-market Notification Details

Device IDK941559
510k NumberK941559
Device Name:PARADERM -585M DERMATOLOGICAL LASER
ClassificationPowered Laser Surgical Instrument
Applicant PARADIGM LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
PARADIGM LASERS, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, N.W. Washington,  DC  20004 -1109
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-01
Decision Date1994-11-03

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