InMode System With The Morhpeus8 Applicators

Electrosurgical, Cutting & Coagulation & Accessories

InMode Ltd.

The following data is part of a premarket notification filed by Inmode Ltd. with the FDA for Inmode System With The Morhpeus8 Applicators.

Pre-market Notification Details

Device IDK200947
510k NumberK200947
Device Name:InMode System With The Morhpeus8 Applicators
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
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 CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-08
Decision Date2020-07-02

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