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FDA 510(k)

InMode System with the Morpheus8 90 Applicator

K-Number: K240017 · 2024-06-13

ApplicantInMode , Ltd.
Decision Date2024-06-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode System with the Morpheus8 90 Applicator is a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2024-06-13 under approval number K240017. 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 90 Applicator?

InMode System with the Morpheus8 90 Applicator is a medical device that received FDA 510(k) clearance on 2024-06-13. It is manufactured by InMode , Ltd.. The 510(k) number is K240017.

When was InMode System with the Morpheus8 90 Applicator approved by the FDA?

InMode System with the Morpheus8 90 Applicator received FDA 510(k) clearance on 2024-06-13, under approval number K240017.

What company makes InMode System with the Morpheus8 90 Applicator?

InMode System with the Morpheus8 90 Applicator is manufactured by InMode , Ltd..

What is the FDA product code for InMode System with the Morpheus8 90 Applicator?

The FDA product code for InMode System with the Morpheus8 90 Applicator 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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