FDA 510(k) Application Details - K151337

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K151337
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Centre Light Solutions, LLC
611 East Douglas Rd. Suite 108
Mishawaka, IN 46545 US
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Contact Carrie Colburn
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 05/19/2015
Decision Date 02/24/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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