Cutera Enlighten III Laser System

Powered Laser Surgical Instrument

Cutera, Inc.

The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Cutera Enlighten Iii Laser System.

Pre-market Notification Details

Device IDK172077
510k NumberK172077
Device Name:Cutera Enlighten III Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Cutera, Inc. 3240 Bayshore Blvd. Brisbane,  CA  94005
ContactBradley Renton
CorrespondentBradley Renton
Cutera, Inc. 3240 Bayshore Blvd. Brisbane,  CA  94005
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-10
Decision Date2017-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816722021625 K172077 000

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