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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Disruption Of Adipocyte Cells For Aesthetic Use
510(k) Number K182741
Device Name SculpSure
Applicant
Cynosure
5 Carlisle Rd.
Wesford,  MA  01886
Applicant Contact Amy Tannenbaum
Correspondent
Cynosure
5 Carlisle Rd.
Wesford,  MA  01886
Correspondent Contact Amy Tannenbaum
Regulation Number878.5400
Classification Product Code
PKT  
Date Received09/28/2018
Decision Date 01/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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