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FDA 510(k)

GME LinScan Lite 808 Laser System

K-Number: K180518 · 2018-07-23

ApplicantGme German Medical Engineering GmbH
Decision Date2018-07-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GME LinScan Lite 808 Laser System is a medical device manufactured by Gme German Medical Engineering GmbH. It received FDA 510(k) clearance on 2018-07-23 under approval number K180518. 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 GME LinScan Lite 808 Laser System?

GME LinScan Lite 808 Laser System is a medical device that received FDA 510(k) clearance on 2018-07-23. It is manufactured by Gme German Medical Engineering GmbH. The 510(k) number is K180518.

When was GME LinScan Lite 808 Laser System approved by the FDA?

GME LinScan Lite 808 Laser System received FDA 510(k) clearance on 2018-07-23, under approval number K180518.

What company makes GME LinScan Lite 808 Laser System?

GME LinScan Lite 808 Laser System is manufactured by Gme German Medical Engineering GmbH.

What is the FDA product code for GME LinScan Lite 808 Laser System?

The FDA product code for GME LinScan Lite 808 Laser System is GEX. This falls under the Gastroenterology category.

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Other Devices by Gme German Medical Engineering 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.

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