CANDELA SPTL-1E PULSED 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 Sptl-1e Pulsed Dye Laser.

Pre-market Notification Details

Device IDK011092
510k NumberK011092
Device Name:CANDELA SPTL-1E PULSED 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 Received2001-04-10
Decision Date2001-07-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.