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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K212891
Device Name TempSure System
Cynosure, LLC
5 Carlisle Road
Westford,  MA  01886
Applicant Contact Michael King
Cynosure, LLC
5 Carlisle Road
Westford,  MA  01886
Correspondent Contact Michael King
Regulation Number878.4400
Classification Product Code
Subsequent Product Code
Date Received09/10/2021
Decision Date 03/18/2022
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