CANDELA SMOOTHBEAM LASER 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 Smoothbeam Laser System.

Pre-market Notification Details

Device IDK014128
510k NumberK014128
Device Name:CANDELA SMOOTHBEAM LASER SYSTEM
ClassificationPowered Laser Surgical Instrument
Applicant CANDELA CORP. 530 BOSTON POST RD. Wayland,  MA  01778
ContactLorraine Nelson
CorrespondentLorraine Nelson
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 Received2001-12-17
Decision Date2002-10-04
Summary:summary

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