FDA 510(k)

NAVILAS Laser System

K-Number: K162191 · 2016-11-22

Decision Date2016-11-22

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

NAVILAS Laser System is a medical device manufactured by Od-Os GmbH. It received FDA 510(k) clearance on 2016-11-22 under approval number K162191. 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 NAVILAS Laser System?

NAVILAS Laser System is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by Od-Os GmbH. The 510(k) number is K162191.

When was NAVILAS Laser System approved by the FDA?

NAVILAS Laser System received FDA 510(k) clearance on 2016-11-22, under approval number K162191.

What company makes NAVILAS Laser System?

NAVILAS Laser System is manufactured by Od-Os GmbH.

What is the FDA product code for NAVILAS Laser System?

The FDA product code for NAVILAS Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

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Other Devices by Od-Os GmbH

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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.