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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 K051922
Device Name ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
Applicant
Cynosure, Inc.
10 Elizabeth Dr.
Chelmsford,  MA  01824
Applicant Contact GEORGE CHO
Correspondent
Cynosure, Inc.
10 Elizabeth Dr.
Chelmsford,  MA  01824
Correspondent Contact GEORGE CHO
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/15/2005
Decision Date 09/14/2005
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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