MULTILINE; DLY-1

Powered Laser Surgical Instrument

DERMA-LASE CO.

The following data is part of a premarket notification filed by Derma-lase Co. with the FDA for Multiline; Dly-1.

Pre-market Notification Details

Device IDK930793
510k NumberK930793
Device Name:MULTILINE; DLY-1
ClassificationPowered Laser Surgical Instrument
Applicant DERMA-LASE CO. 3 MAIN ST. Hopkinton,  MA  01748
ContactMichael Barretti
CorrespondentMichael Barretti
DERMA-LASE CO. 3 MAIN ST. Hopkinton,  MA  01748
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-02-16
Decision Date1993-08-19

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