DERMA-LASE DLA-1 LASER

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 Dla-1 Laser.

Pre-market Notification Details

Device IDK930975
510k NumberK930975
Device Name:DERMA-LASE DLA-1 LASER
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 Received1993-02-24
Decision Date1993-08-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.