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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) 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. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K180719.

When did InMode Diolaze System receive FDA 510(k) clearance?

InMode Diolaze System received FDA 510(k) clearance on 2018-06-14, under 510(k) number K180719.

Who is the listed applicant for InMode Diolaze System?

The FDA 510(k) record lists Inmode MD , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Inmode MD , 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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