InMode System With VTone Applicator

Stimulator, Electrical, Non-implantable, For Incontinence

InMode Ltd.

The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Inmode System With Vtone Applicator.

Pre-market Notification Details

Device IDK200293
510k NumberK200293
Device Name:InMode System With VTone Applicator
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant InMode Ltd. Tabor Building, Shaar Yokneam Yoqneam Illit,  IL 2069200
ContactAmit Goren
CorrespondentAmit Goren
A. Stein – Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba,  IL 4442520
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-05
Decision Date2020-05-05

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