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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 K150230
Device Name SculpSure
Applicant
CYNOSURE, INC.
5 CARLISLE ROAD
westford,  MA  01886
Applicant Contact kevin o'connell
Correspondent
CYNOSURE, INC.
5 CARLISLE ROAD
westford,  MA  01886
Correspondent Contact kevin o'connell
Regulation Number878.5400
Classification Product Code
PKT  
Date Received02/02/2015
Decision Date 05/15/2015
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
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