InMode Diolaze System
K-Number: K180719 · 2018-06-14
ApplicantInmode MD , Ltd.
Decision Date2018-06-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
InMode Diolaze System is a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2018-06-14 under approval number K180719. 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 Diolaze System?
InMode Diolaze System is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K180719.
When was InMode Diolaze System approved by the FDA?
InMode Diolaze System received FDA 510(k) clearance on 2018-06-14, under approval number K180719.
What company makes InMode Diolaze System?
InMode Diolaze System is manufactured by Inmode MD , Ltd..
What is the FDA product code for InMode Diolaze System?
The FDA product code for InMode Diolaze 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.