SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM 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 Sidelaze800 Laser Beam Delivery Accessory For Cynosure 1440mm Wavelength Lasers.

Pre-market Notification Details

Device IDK141511
510k NumberK141511
Device Name:SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERS
ClassificationPowered Laser Surgical Instrument
Applicant CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
ContactHuda Yusuf
CorrespondentAastha Kohli
CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-09
Decision Date2015-01-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494100452 K141511 000

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