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FDA 510(k)

Beacon Advanced CO2 Laser System

K-Number: K180993 · 2018-06-28

ApplicantOmniguide, Inc.
Decision Date2018-06-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Beacon Advanced CO2 Laser System is a medical device manufactured by Omniguide, Inc.. It received FDA 510(k) clearance on 2018-06-28 under approval number K180993. 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 Beacon Advanced CO2 Laser System?

Beacon Advanced CO2 Laser System is a medical device that received FDA 510(k) clearance on 2018-06-28. It is manufactured by Omniguide, Inc.. The 510(k) number is K180993.

When was Beacon Advanced CO2 Laser System approved by the FDA?

Beacon Advanced CO2 Laser System received FDA 510(k) clearance on 2018-06-28, under approval number K180993.

What company makes Beacon Advanced CO2 Laser System?

Beacon Advanced CO2 Laser System is manufactured by Omniguide, Inc..

What is the FDA product code for Beacon Advanced CO2 Laser System?

The FDA product code for Beacon Advanced CO2 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 Omniguide, Inc.

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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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