DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST

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 Dlr-1 Derma-lase Ruby Laser/dlr-1/derma-lase Syst.

Pre-market Notification Details

Device IDK924647
510k NumberK924647
Device Name:DLR-1 DERMA-LASE RUBY LASER/DLR-1/DERMA-LASE SYST
ClassificationPowered Laser Surgical Instrument
Applicant DERMA-LASE CO. 3 MAIN ST. Hopkinton,  MA  01748
ContactMichael L Barretti
CorrespondentMichael L 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 Received1992-09-14
Decision Date1993-06-04

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