FDA 510(k)

Diode laser device (RF3120-BI)

Número K: K251329 · 2025-06-27

RequerenteRisu Medical Technology Co., Ltd.

Data da decisão2025-06-27

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Diode laser device (RF3120-BI) is the device name listed in this FDA 510(k) record. The listed applicant is Risu Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K251329. 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 Diode laser device (RF3120-BI)?

Diode laser device (RF3120-BI) is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Risu Medical Technology Co., Ltd.. The 510(k) number is K251329.

When did Diode laser device (RF3120-BI) receive FDA 510(k) clearance?

Diode laser device (RF3120-BI) received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251329.

Who is the listed applicant for Diode laser device (RF3120-BI)?

The FDA 510(k) record lists Risu Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode laser device (RF3120-BI)?

The FDA product code for Diode laser device (RF3120-BI) is GEX. This falls under the Gastroenterology category.

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