CANDELA FLUORESCENT PULSED LIGHT 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 Fluorescent Pulsed Light System.

Pre-market Notification Details

Device IDK063800
510k NumberK063800
Device Name:CANDELA FLUORESCENT PULSED LIGHT SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST ROAD Wayland,  MA  01778
ContactJeffrey Roberts
CorrespondentJeffrey Roberts
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 Received2006-12-22
Decision Date2007-02-05
Summary:summary

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