FDA 510(k) Application Details - K072459

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K072459
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant PHOTO THERAPEUTICS, INC.
2720 LOKER AVENUE WEST
CARLSBAD, CA 92010 US
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Contact SUE DARCY
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 08/31/2007
Decision Date 03/03/2008
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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