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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K123971
Device Name CYNOSURE 1064NM DIODE LASER
Applicant
Cynosure, Inc.
5 Carlisle Rd.
Wesford,  MA  01886
Applicant Contact IRINA KULINETS
Correspondent
Cynosure, Inc.
5 Carlisle Rd.
Wesford,  MA  01886
Correspondent Contact IRINA KULINETS
Regulation Number890.5500
Classification Product Code
ILY  
Date Received12/26/2012
Decision Date 05/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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