DERMA-LASE RUBY LASER - MODEL DLR-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 Derma-lase Ruby Laser - Model Dlr-1.

Pre-market Notification Details

Device IDK913256
510k NumberK913256
Device Name:DERMA-LASE RUBY LASER - MODEL DLR-1
ClassificationPowered Laser Surgical Instrument
Applicant DERMA-LASE CO. WARD MEMORIAL BUILDING 303 EAST CHICAGO AVENUE Chicago,  IL  60611
ContactJerome M Garden
CorrespondentJerome M Garden
DERMA-LASE CO. WARD MEMORIAL BUILDING 303 EAST CHICAGO AVENUE Chicago,  IL  60611
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-16
Decision Date1992-01-22

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