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FDA 510(k)

LGO-Surgical Laser Fibers

K-Number: K243147 · 2024-12-21

ApplicantLight Guide Optics International , Ltd.
Decision Date2024-12-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LGO-Surgical Laser Fibers is a medical device manufactured by Light Guide Optics International , Ltd.. It received FDA 510(k) clearance on 2024-12-21 under approval number K243147. 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 LGO-Surgical Laser Fibers?

LGO-Surgical Laser Fibers is a medical device that received FDA 510(k) clearance on 2024-12-21. It is manufactured by Light Guide Optics International , Ltd.. The 510(k) number is K243147.

When was LGO-Surgical Laser Fibers approved by the FDA?

LGO-Surgical Laser Fibers received FDA 510(k) clearance on 2024-12-21, under approval number K243147.

What company makes LGO-Surgical Laser Fibers?

LGO-Surgical Laser Fibers is manufactured by Light Guide Optics International , Ltd..

What is the FDA product code for LGO-Surgical Laser Fibers?

The FDA product code for LGO-Surgical Laser Fibers is GEX. This falls under the Gastroenterology category.

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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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