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FDA 510(k)

InMode Multi-system

K-Number: K221571 · 2022-06-30

ApplicantInMode , Ltd.
Decision Date2022-06-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode Multi-system is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K221571. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InMode Multi-system?

InMode Multi-system is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is InMode , Ltd.. The 510(k) number is K221571.

When did InMode Multi-system receive FDA 510(k) clearance?

InMode Multi-system received FDA 510(k) clearance on 2022-06-30, under 510(k) number K221571.

Who is the listed applicant for InMode Multi-system?

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 InMode Multi-system?

The FDA product code for InMode Multi-system is GEX. This falls under the Gastroenterology category.

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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