CANDELA GENTLELASE GL DERMATOLOGICAL LASER

Powered Laser Surgical Instrument

CANDELA CORP.

The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Gentlelase Gl Dermatological Laser.

Pre-market Notification Details

Device IDK974381
510k NumberK974381
Device Name:CANDELA GENTLELASE GL DERMATOLOGICAL LASER
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactJan Caplan
CorrespondentJan Caplan
CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-20
Decision Date1998-02-10
Summary:summary

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