SculpSure

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

CYNOSURE, INC.

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

Pre-market Notification Details

Device IDK150230
510k NumberK150230
Device Name:SculpSure
ClassificationLaser For Disruption Of Adipocyte Cells For Aesthetic Use
Applicant CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
ContactKevin O'connell
CorrespondentKevin O'connell
CYNOSURE, INC. 5 CARLISLE ROAD Westford,  MA  01886
Product CodePKT  
CFR Regulation Number878.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-05-15
Summary:summary

Trademark Results [SculpSure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SCULPSURE
SCULPSURE
86964533 5283577 Live/Registered
CYNOSURE, LLC
2016-04-05
SCULPSURE
SCULPSURE
86383950 4882549 Live/Registered
CYNOSURE, LLC
2014-09-03

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