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FDA 510(k) Application Details - K172302
Device Classification Name
More FDA Info for this Device
510(K) Number
K172302
Device Name
InMode PLUS System
Applicant
InMode MD Ltd.
Tabor Building
Shaar Yokneam
Yoqneam Illit 2069200 IL
Other 510(k) Applications for this Company
Contact
Amit Goren
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
07/31/2017
Decision Date
12/08/2017
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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