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FDA 510(k)

InMode System with the Morpheus8 (Fractora) Applicators

K-Number: K192695 · 2019-12-27

ApplicantInmode MD , Ltd.
Decision Date2019-12-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode System with the Morpheus8 (Fractora) Applicators is a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2019-12-27 under approval number K192695. 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 Morpheus8 (Fractora) Applicators?

InMode System with the Morpheus8 (Fractora) Applicators is a medical device that received FDA 510(k) clearance on 2019-12-27. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K192695.

When was InMode System with the Morpheus8 (Fractora) Applicators approved by the FDA?

InMode System with the Morpheus8 (Fractora) Applicators received FDA 510(k) clearance on 2019-12-27, under approval number K192695.

What company makes InMode System with the Morpheus8 (Fractora) Applicators?

InMode System with the Morpheus8 (Fractora) Applicators is manufactured by Inmode MD , Ltd..

What is the FDA product code for InMode System with the Morpheus8 (Fractora) Applicators?

The FDA product code for InMode System with the Morpheus8 (Fractora) 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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