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FDA 510(k) Application Details - K153568
Device Classification Name
More FDA Info for this Device
510(K) Number
K153568
Device Name
InMode Plus System
Applicant
InMode MD Ltd.
Tabor Building, Shaar Yokneam, POB 44
Yoqneam 20692 IL
Other 510(k) Applications for this Company
Contact
Ahava Stein
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
12/14/2015
Decision Date
07/12/2016
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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