InMode PLUS System

Massager, Vacuum, Radio Frequency Induced Heat

InMode MD Ltd.

The following data is part of a premarket notification filed by Inmode Md Ltd. with the FDA for Inmode Plus System.

Pre-market Notification Details

Device IDK172302
510k NumberK172302
Device Name:InMode PLUS System
ClassificationMassager, Vacuum, Radio Frequency Induced Heat
Applicant InMode MD 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 CodePBX  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-31
Decision Date2017-12-08
Summary:summary

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