FDA 510(k) Application Details - K221444

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K221444
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Light Tree Ventures Europe B.V.
Laan van Ypenburg 108, 2497 GC
The Hague NL
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Contact Kim Laurens
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 05/18/2022
Decision Date 12/08/2022
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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