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FDA 510(k)

InMode VLaze

K-Number: K173677 · 2018-02-23

ApplicantInmode MD , Ltd.
Decision Date2018-02-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode VLaze 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 2018-02-23 under 510(k) number K173677. 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 VLaze?

InMode VLaze is a medical device that received FDA 510(k) clearance on 2018-02-23. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K173677.

When did InMode VLaze receive FDA 510(k) clearance?

InMode VLaze received FDA 510(k) clearance on 2018-02-23, under 510(k) number K173677.

Who is the listed applicant for InMode VLaze?

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 VLaze?

The FDA product code for InMode VLaze 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.

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