FDA 510(k)

LGO 수술 레이저 섬유

K-번호: K243147 · 2024-12-21

신청자Light Guide Optics International , Ltd.

결정일2024-12-21

제품 코드GEX

자문 위원회SU

결정Substantially Equivalent

기기 요약

LGO-Surgical Laser Fibers is the device name listed in this FDA 510(k) record. The listed applicant is Light Guide Optics International , Ltd.. It received FDA 510(k) clearance on 2024-12-21 under 510(k) 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.

자주 묻는 질문

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. The listed applicant is Light Guide Optics International , Ltd.. The 510(k) number is K243147.

When did LGO-Surgical Laser Fibers receive FDA 510(k) clearance?

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

Who is the listed applicant for LGO-Surgical Laser Fibers?

The FDA 510(k) record lists Light Guide Optics International , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

LGO 수술 레이저 섬유

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GEX)

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