CANDELA GENTLE YAG LASER SYSTEM

Powered Laser Surgical Instrument

CANDELA CORP.

The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Gentle Yag Laser System.

Pre-market Notification Details

Device IDK022923
510k NumberK022923
Device Name:CANDELA GENTLE YAG LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactLorraine Nelson
CorrespondentLorraine Nelson
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 Received2002-09-04
Decision Date2003-03-13
Summary:summary

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