CANDELA GENTLELASE FAMILY OF LASER SYSTEMS

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 Family Of Laser Systems.

Pre-market Notification Details

Device IDK024260
510k NumberK024260
Device Name:CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactWilliam H Mcgrail
CorrespondentWilliam H Mcgrail
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 Received2002-12-23
Decision Date2003-03-21
Summary:summary

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