FDA 510(k) Application Details - K123407

Device Classification Name

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510(K) Number K123407
Device Name CELLULAZE LASER
Applicant CYNOSURE, INC.
5 CARLISLE ROAD
WESTFORD, MA 01886 US
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Contact IRINA KULINETS
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Regulation Number

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Classification Product Code OYW
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Date Received 11/05/2012
Decision Date 03/29/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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