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 IDK151793
510k NumberK151793
Device Name:InMode RF System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant INMODE MD LTD. TABOR BUILDING, SHAAR YOKNEAM Yoqneam Illit,  IL 2069200
ContactAhava Stein
CorrespondentAhava Stein
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-01
Decision Date2016-02-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290016633344 K151793 000
07290016633337 K151793 000
07290016633016 K151793 000
17290016633211 K151793 000

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