Family Of CoolGlide Aesthetic Lasers

Powered Laser Surgical Instrument

CUTERA, INC.

The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Family Of Coolglide Aesthetic Lasers.

Pre-market Notification Details

Device IDK153671
510k NumberK153671
Device Name:Family Of CoolGlide Aesthetic Lasers
ClassificationPowered Laser Surgical Instrument
Applicant CUTERA, INC. 3240 BAYSHORE BLVD. Brisbane,  CA  94005
ContactJulia Brown
CorrespondentJulia Brown
CUTERA, INC. 3240 BAYSHORE BLVD. Brisbane,  CA  94005
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-12-21
Decision Date2016-03-09
Summary:summary

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