FDA 510(k) Application Details - K131870

Device Classification Name Light Based Over-The-Counter Hair Removal

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510(K) Number K131870
Device Name Light Based Over-The-Counter Hair Removal
Applicant HOME SKINOVATIONS LTD.
20 HATA'AS STR., STE 102
KFAR SABA 44425 IL
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Contact AHAVA STEIN
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 06/24/2013
Decision Date 08/14/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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