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FDA 510(k) Application Details - K151337
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
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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More FDA Info for this Product Code
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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