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FDA 510(k) Application Details - K192010
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K192010
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
CyDen Limited
Block A, Bay Studios Business Park, Fabian Way
Swansea SA1 8QB GB
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Contact
Adam Stephens
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
07/29/2019
Decision Date
09/24/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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