CANDELA GENTLELASE 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 Gentlelase Family Of Lasers.

Pre-market Notification Details

Device IDK111144
510k NumberK111144
Device Name:CANDELA GENTLELASE FAMILY OF LASERS
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST ROAD Wayland,  MA  01778
ContactScott Blood
CorrespondentScott Blood
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 Received2011-04-22
Decision Date2011-07-18
Summary:summary

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