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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light based over the counter wrinkle reduction
510(k) Number K111454
Device Name ILUMINAGE DIODE LASER
Applicant
CYNOSURE, INC.
5 CARLISLE ROAD
WESTFORD,  MA  01886
Applicant Contact GEORGE CHO
Correspondent
CYNOSURE, INC.
5 CARLISLE ROAD
WESTFORD,  MA  01886
Correspondent Contact GEORGE CHO
Regulation Number878.4810
Classification Product Code
OHS  
Subsequent Product Code
GEX  
Date Received05/25/2011
Decision Date 07/05/2012
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
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