FDA 510(k)

Medical Thulium Fiber Laser Systems (UroFiber 150Q)

Número K: K261738 · 2026-07-21

RequerenteRhein Laser Technologies Co., Ltd.

Data da decisão2026-07-21

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Thulium Fiber Laser Systems (UroFiber 150Q) is the device name listed in this FDA 510(k) record. The listed applicant is Rhein Laser Technologies Co., Ltd.. It received FDA 510(k) clearance on 2026-07-21 under 510(k) number K261738. 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.

Perguntas frequentes

What is the Medical Thulium Fiber Laser Systems (UroFiber 150Q)?

Medical Thulium Fiber Laser Systems (UroFiber 150Q) is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Rhein Laser Technologies Co., Ltd.. The 510(k) number is K261738.

When did Medical Thulium Fiber Laser Systems (UroFiber 150Q) receive FDA 510(k) clearance?

Medical Thulium Fiber Laser Systems (UroFiber 150Q) received FDA 510(k) clearance on 2026-07-21, under 510(k) number K261738.

Who is the listed applicant for Medical Thulium Fiber Laser Systems (UroFiber 150Q)?

The FDA 510(k) record lists Rhein Laser Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Thulium Fiber Laser Systems (UroFiber 150Q)?

The FDA product code for Medical Thulium Fiber Laser Systems (UroFiber 150Q) is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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