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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 K141425
Device Name ELITE + LASER SYSTEM
Applicant
CYNOSURE, INC.
5 CARLISLE ROAD
WESTFORD,  MA  01886
Applicant Contact KELLI MCMILLAN
Correspondent
CYNOSURE, INC.
5 CARLISLE ROAD
WESTFORD,  MA  01886
Correspondent Contact KELLI MCMILLAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/30/2014
Decision Date 09/11/2014
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
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