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FDA 510(k)

Optimas MAX System

K-Number: K251632 · 2025-06-26

ApplicantInMode , Ltd.
Decision Date2025-06-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Optimas MAX 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 2025-06-26 under 510(k) number K251632. 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 Optimas MAX System?

Optimas MAX System is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is InMode , Ltd.. The 510(k) number is K251632.

When did Optimas MAX System receive FDA 510(k) clearance?

Optimas MAX System received FDA 510(k) clearance on 2025-06-26, under 510(k) number K251632.

Who is the listed applicant for Optimas MAX 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 Optimas MAX System?

The FDA product code for Optimas MAX 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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