TruSculpt

Massager, Vacuum, Radio Frequency Induced Heat

CUTERA, INC.

The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Trusculpt.

Pre-market Notification Details

Device IDK162512
510k NumberK162512
Device Name:TruSculpt
ClassificationMassager, Vacuum, Radio Frequency Induced Heat
Applicant CUTERA, INC. 3240 BAYSHORE BLVD. Brisbane,  CA  94005
ContactBradley Renton
CorrespondentBradley Renton
CUTERA, INC. 3240 BAYSHORE BLVD. Brisbane,  CA  94005
Product CodePBX  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-08
Decision Date2016-12-09
Summary:summary

Trademark Results [TruSculpt]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUSCULPT
TRUSCULPT
77662751 4125795 Live/Registered
Cutera, Inc.
2009-02-03
TRUSCULPT
TRUSCULPT
75207760 2268025 Dead/Cancelled
Franklin Mint Company
1996-12-04

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