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 a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2025-06-26 under approval 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. It is manufactured by InMode , Ltd.. The 510(k) number is K251632.
When was Optimas MAX System approved by the FDA?
Optimas MAX System received FDA 510(k) clearance on 2025-06-26, under approval number K251632.
What company makes Optimas MAX System?
Optimas MAX System is manufactured by InMode , Ltd..
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.
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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.