InMode RF Multi-System

Electrosurgical, Cutting & Coagulation & Accessories

InMode Ltd.

The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Inmode Rf Multi-system.

Pre-market Notification Details

Device IDK201150
510k NumberK201150
Device Name:InMode RF Multi-System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant InMode Ltd. Tabor Building, Shaar Yokneam Yokneam Illit,  IL 2069200
ContactAmit Goren
CorrespondentAmit Goren
A. Stein - Regulatory Affairs Consulting Ltd. 20 Hata'as Str., Suite 102 Kfar Saba,  IL 4442520
Product CodeGEI  
Subsequent Product CodeISA
Subsequent Product CodeNUV
Subsequent Product CodePBX
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-29
Decision Date2020-07-22

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