SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS

Powered Laser Surgical Instrument

CYNOSURE, INC.

The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Sidelaze Laser Beam Delivery Accessory For Cynosure 1440nm Wavelength Lasers.

Pre-market Notification Details

Device IDK121127
510k NumberK121127
Device Name:SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERS
ClassificationPowered Laser Surgical Instrument
Applicant CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
ContactIrina Kulinets
CorrespondentIrina Kulinets
CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-13
Decision Date2012-05-13
Summary:summary

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