FDA 510(k)

LIGHTFUSION LED SYSTEM

K-Number: K162556 · 2017-03-24

Decision Date2017-03-24

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LIGHTFUSION LED SYSTEM is a medical device manufactured by Vitage Led, Ltd.. It received FDA 510(k) clearance on 2017-03-24 under approval number K162556. 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 LIGHTFUSION LED SYSTEM?

LIGHTFUSION LED SYSTEM is a medical device that received FDA 510(k) clearance on 2017-03-24. It is manufactured by Vitage Led, Ltd.. The 510(k) number is K162556.

When was LIGHTFUSION LED SYSTEM approved by the FDA?

LIGHTFUSION LED SYSTEM received FDA 510(k) clearance on 2017-03-24, under approval number K162556.

What company makes LIGHTFUSION LED SYSTEM?

LIGHTFUSION LED SYSTEM is manufactured by Vitage Led, Ltd..

What is the FDA product code for LIGHTFUSION LED SYSTEM?

The FDA product code for LIGHTFUSION LED SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.