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 IDK171992
510k NumberK171992
Device Name:Sculpsure
ClassificationLaser For Disruption Of Adipocyte Cells For Aesthetic Use
Applicant Cynosure, Inc 5 Carlisle Road Westford,  MA  01886
ContactAmy Tannenbaum
CorrespondentAmy Tannenbaum
Cynosure, Inc 5 Carlisle Road Westford,  MA  01886
Product CodePKT  
CFR Regulation Number878.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-03
Decision Date2017-09-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00841494107994 K171992 000
00841494107963 K171992 000
00841494107956 K171992 000
00841494107468 K171992 000

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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