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 a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2018-02-23 under approval 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. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K173677.
When was InMode VLaze approved by the FDA?
InMode VLaze received FDA 510(k) clearance on 2018-02-23, under approval number K173677.
What company makes InMode VLaze?
InMode VLaze is manufactured by Inmode MD , Ltd..
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.