CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE 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 Family Of Q-switched Alexandrite Lasers.

Pre-market Notification Details

Device IDK081324
510k NumberK081324
Device Name:CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST ROAD Wayland,  MA  01778
ContactLisa Lacroix
CorrespondentLisa Lacroix
CANDELA CORP. 530 BOSTON POST ROAD Wayland,  MA  01778
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-05-12
Decision Date2008-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00817495021133 K081324 000

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