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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / October 2025 / K252345

510(k) cleared

Picosecond Laser Device (PF131-BI)

Risu Medical Technology Co., Ltd. · Oct 23, 2025 · K252345

FDA cleared the Picosecond Laser Device (PF131-BI) from Risu Medical Technology Co., Ltd. on Oct 23, 2025 under K252345, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 28, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Risu Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252345?

K252345 is the FDA 510(k) for Picosecond Laser Device (PF131-BI), submitted by Risu Medical Technology Co., Ltd.. FDA's decision date was Oct 23, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Picosecond Laser Device (PF131-BI)?

Risu Medical Technology Co., Ltd., based in Fengxi New City Of Xixian New Area, is the applicant of record for K252345.

How long did the K252345 review take?

FDA received the submission on Jul 28, 2025 and issued its decision on Oct 23, 2025, 87 days later.

← All decisions in October 2025