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FDA 510(k)

The InMode System with the Morpheus8 Applicators

K-Number: K231790 · 2023-07-20

ApplicantInMode , Ltd.
Decision Date2023-07-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The InMode System with the Morpheus8 Applicators is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2023-07-20 under 510(k) number K231790. 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 The InMode System with the Morpheus8 Applicators?

The InMode System with the Morpheus8 Applicators is a medical device that received FDA 510(k) clearance on 2023-07-20. The listed applicant is InMode , Ltd.. The 510(k) number is K231790.

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

The InMode System with the Morpheus8 Applicators received FDA 510(k) clearance on 2023-07-20, under 510(k) number K231790.

Who is the listed applicant for The InMode System with the Morpheus8 Applicators?

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

What is the FDA product code for The InMode System with the Morpheus8 Applicators?

The FDA product code for The InMode System with the Morpheus8 Applicators is GEI.

Other records listing InMode , Ltd. as applicant

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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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