InMode RF System

Electrosurgical, Cutting & Coagulation & Accessories

Inmode MD Ltd.

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

Pre-market Notification Details

Device IDK182325
510k NumberK182325
Device Name:InMode RF System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
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 CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-27
Decision Date2018-09-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290016633481 K182325 000
07290019863250 K182325 000
07290016633368 K182325 000

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