CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B

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 Pulsed Dye Laser Systems, Models Vbeam, Cbeam, Sptl-1b.

Pre-market Notification Details

Device IDK043251
510k NumberK043251
Device Name:CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactLorraine Calzetta
CorrespondentLorraine Calzetta
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 Received2004-11-23
Decision Date2005-02-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817495023496 K043251 000
00817495020006 K043251 000
00817495021447 K043251 000
00817495021423 K043251 000
00817495021362 K043251 000

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