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FDA 510(k) Application Details - K131870
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
OHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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