SMARTLIPO ND:YAG LASER

Powered Laser Surgical Instrument

CYNOSURE, INC.

The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Smartlipo Nd:yag Laser.

Pre-market Notification Details

Device IDK062321
510k NumberK062321
Device Name:SMARTLIPO ND:YAG LASER
ClassificationPowered Laser Surgical Instrument
Applicant CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
ContactGeorge Cho
CorrespondentGeorge Cho
CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-09
Decision Date2006-10-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08057017760474 K062321 000

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