FDA 510(k)

皮秒激光设备（PF131-BI）

K号: K252345 · 2025-10-23

决定日期2025-10-23

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Risu Medical Technology Co., Ltd.为申报人的其他记录

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K251329二极管激光设备（RF3120-BI）

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