FDA 510(k) Application Details - K222685

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K222685
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Dermal Photonics Corp
153 Andover St, Ste 111
Danvers, MA 01923 US
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Contact Felix Feldchtein
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 09/06/2022
Decision Date 02/08/2023
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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