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FDA 510(k)

Picosecond Laser Device (PF131-BI)

K-Number: K252345 · 2025-10-23

ApplicantRisu Medical Technology Co., Ltd.
Decision Date2025-10-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Risu Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251329Diode laser device (RF3120-BI)

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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