FDA 510(k) Application Details - K162784

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K162784
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Home Skinovations Ltd.
Tabor Building, Shaar Yokneam
Yoqneam Illit 2069200 IL
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Contact Amit Goren
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 10/03/2016
Decision Date 03/25/2017
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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