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FDA 510(k) Application Details - K183260
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K183260
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
EL Global Trade Ltd.
8 Tzoran St, P.O. Box 8242
Netanya 4250608 IL
Other 510(k) Applications for this Company
Contact
Shachar Raz
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/23/2018
Decision Date
03/18/2019
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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