CUTERA PICOSECOND 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 Picosecond Laser System.

Pre-market Notification Details

Device IDK140727
510k NumberK140727
Device Name:CUTERA PICOSECOND 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 Received2014-03-24
Decision Date2014-11-06
Summary:summary

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