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 IDK132185
510k NumberK132185
Device Name:FAMILY OF COOLGLIDE AESTHETIC LASERS
ClassificationPowered Laser Surgical Instrument
Applicant CUTERA, INC. 3240 BAYSHORE BLVD Brisbane,  CA  94005
ContactSandra Hansen
CorrespondentSandra Hansen
CUTERA, INC. 3240 BAYSHORE BLVD Brisbane,  CA  94005
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-07-15
Decision Date2013-12-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816722022318 K132185 000
00816722022349 K132185 000
00816722021311 K132185 000
00816722022325 K132185 000
00816722022356 K132185 000
08167222022349 K132185 000
00816722021304 K132185 000
00816722021502 K132185 000
00816722022301 K132185 000
00816722022363 K132185 000

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