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FDA 510(k) Application Details - K143003
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K143003
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Ipulse Limited
Technium 2, Kings Road, The Docks
Swansea Sa1 8pJ GB
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Contact
Mike Kiernan
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
10/20/2014
Decision Date
06/18/2015
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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