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FDA 510(k) Application Details - K201064
Device Classification Name
More FDA Info for this Device
510(K) Number
K201064
Device Name
V30 System, V20 System, V10 System, V-FR Handpiece
Applicant
Viora Ltd.
6 Hagavish Street
Neanya 4250706 IL
Other 510(k) Applications for this Company
Contact
Simona F. Krant
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PBX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/21/2020
Decision Date
07/15/2020
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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