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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 the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2019-12-27 under 510(k) 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. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K192695.

When did InMode System with the Morpheus8 (Fractora) Applicators receive FDA 510(k) clearance?

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

Who is the listed applicant for InMode System with the Morpheus8 (Fractora) Applicators?

The FDA 510(k) record lists Inmode MD , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Related Devices (Code: 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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