CANDELA GENTLEMAX FAMILY OF LASERS

Powered Laser Surgical Instrument

CANDELA CORP.

The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Gentlemax Family Of Lasers.

Pre-market Notification Details

Device IDK112715
510k NumberK112715
Device Name:CANDELA GENTLEMAX FAMILY OF LASERS
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST ROAD Wayland,  MA  01778
ContactSam Wade
CorrespondentSam Wade
CANDELA CORP. 530 BOSTON POST ROAD Wayland,  MA  01778
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-19
Decision Date2011-10-05
Summary:summary

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