FDA 510(k)

InMode Multi-system

K-Number: K221571 · 2022-06-30

Decision Date2022-06-30

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

InMode Multi-system is a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2022-06-30 under approval 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. It is manufactured by InMode , Ltd.. The 510(k) number is K221571.

When was InMode Multi-system approved by the FDA?

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

What company makes InMode Multi-system?

InMode Multi-system is manufactured by InMode , Ltd..

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.

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Related PubMed Literature

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Other Devices by InMode , Ltd.

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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.