CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES

Powered Laser Surgical Instrument

CANDELA LASER CORP.

The following data is part of a premarket notification filed by Candela Laser Corp. with the FDA for Candela Sptl-1 Laser For Treating Benign Vasc. Les.

Pre-market Notification Details

Device IDK900858
510k NumberK900858
Device Name:CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA LASER CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactGeorge Cho
CorrespondentGeorge Cho
CANDELA LASER CORP. 530 BOSTON POST RD. Wayland,  MA  01778
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-23
Decision Date1990-10-03

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