CANDELA SCLERO LONG PULSE DYE LASER

Powered Laser Surgical Instrument

CANDELA CORP.

The following data is part of a premarket notification filed by Candela Corp. with the FDA for Candela Sclero Long Pulse Dye Laser.

Pre-market Notification Details

Device IDK993671
510k NumberK993671
Device Name:CANDELA SCLERO LONG PULSE DYE LASER
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactJoan Clifford
CorrespondentJoan Clifford
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 Received1999-11-01
Decision Date2000-01-24
Summary:summary

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