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FDA 510(k)

TwinScan 808/755 Laser System

K-Number: K192269 · 2019-11-19

ApplicantGme German Medical Engineering GmbH
Decision Date2019-11-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TwinScan 808/755 Laser System is a medical device manufactured by Gme German Medical Engineering GmbH. It received FDA 510(k) clearance on 2019-11-19 under approval number K192269. 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 TwinScan 808/755 Laser System?

TwinScan 808/755 Laser System is a medical device that received FDA 510(k) clearance on 2019-11-19. It is manufactured by Gme German Medical Engineering GmbH. The 510(k) number is K192269.

When was TwinScan 808/755 Laser System approved by the FDA?

TwinScan 808/755 Laser System received FDA 510(k) clearance on 2019-11-19, under approval number K192269.

What company makes TwinScan 808/755 Laser System?

TwinScan 808/755 Laser System is manufactured by Gme German Medical Engineering GmbH.

What is the FDA product code for TwinScan 808/755 Laser System?

The FDA product code for TwinScan 808/755 Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Gme German Medical Engineering GmbH

K180518GME LinScan Lite 808 Laser System K203054FlexSys K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm

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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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