FDA 510(k)

Medical Thulium Fiber Laser Systems (UroFiber 150Q)

N.º K: K261738 · 2026-07-21

SolicitanteRhein Laser Technologies Co., Ltd.

Fecha de decisión2026-07-21

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

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Otros registros que enlistan a Rhein Laser Technologies Co., Ltd. como solicitante

K242293Medical Thulium Fiber Laser Systems (UroFiber 60Q)K233757TitanPico Laser Workstation (PICO-450)K233756Sistema de Laser Diodo Artemis (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)

Dispositivos relacionados (Código: GEX)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.