FDA 510(k) Application Details - K133473

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K133473
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant CYNOSURE, INC.
5 CARLISLE ROAD
WESTFORD, MA 01886 US
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Contact KEVIN O'CONNELL
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 11/12/2013
Decision Date 01/15/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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