FDA 510(k) Application Details - K172302

Device Classification Name

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510(K) Number K172302
Device Name InMode PLUS System
Applicant InMode MD Ltd.
Tabor Building
Shaar Yokneam
Yoqneam Illit 2069200 IL
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Contact Amit Goren
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Regulation Number

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Classification Product Code PBX
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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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