FDA 510(k)

Picosecond Laser Device (PF131-BI)

Número K: K252345 · 2025-10-23

RequerenteRisu Medical Technology Co., Ltd.

Data da decisão2025-10-23

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Picosecond Laser Device (PF131-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 2025-10-23 under 510(k) number K252345. 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 Picosecond Laser Device (PF131-BI)?

Picosecond Laser Device (PF131-BI) is a medical device that received FDA 510(k) clearance on 2025-10-23. The listed applicant is Risu Medical Technology Co., Ltd.. The 510(k) number is K252345.

When did Picosecond Laser Device (PF131-BI) receive FDA 510(k) clearance?

Picosecond Laser Device (PF131-BI) received FDA 510(k) clearance on 2025-10-23, under 510(k) number K252345.

Who is the listed applicant for Picosecond Laser Device (PF131-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 Picosecond Laser Device (PF131-BI)?

The FDA product code for Picosecond Laser Device (PF131-BI) is GEX. This falls under the Gastroenterology category.

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