CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH

Powered Laser Surgical Instrument

CYNOSURE, INC.

The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Smartlipo Multiwavelength Laser With 1440nm Wavelength.

Pre-market Notification Details

Device IDK091537
510k NumberK091537
Device Name:CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH
ClassificationPowered Laser Surgical Instrument
Applicant CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
ContactAnthony Burns
CorrespondentAnthony Burns
CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-26
Decision Date2009-09-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494100445 K091537 000
00841494100438 K091537 000
00841494100353 K091537 000

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