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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K142376
Device Name Palomar Icon Aesthetic System
Applicant
Cynosure, Inc.
5 Carlisle Rd.
Wesford,  MA  01886
Applicant Contact Allyson Connor
Correspondent
Cynosure, Inc.
5 Carlisle Rd.
Wesford,  MA  01886
Correspondent Contact Allyson Connor
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received08/26/2014
Decision Date 09/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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