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FDA 510(k)

InMode System with the Morhpeus8 Applicators

K-Number: K200947 · 2020-07-02

ApplicantInMode , Ltd.
Decision Date2020-07-02
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode System with the Morhpeus8 Applicators is a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2020-07-02 under approval number K200947. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InMode System with the Morhpeus8 Applicators?

InMode System with the Morhpeus8 Applicators is a medical device that received FDA 510(k) clearance on 2020-07-02. It is manufactured by InMode , Ltd.. The 510(k) number is K200947.

When was InMode System with the Morhpeus8 Applicators approved by the FDA?

InMode System with the Morhpeus8 Applicators received FDA 510(k) clearance on 2020-07-02, under approval number K200947.

What company makes InMode System with the Morhpeus8 Applicators?

InMode System with the Morhpeus8 Applicators is manufactured by InMode , Ltd..

What is the FDA product code for InMode System with the Morhpeus8 Applicators?

The FDA product code for InMode System with the Morhpeus8 Applicators is GEI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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