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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 / July 2026 / K261738

510(k) cleared

Medical Thulium Fiber Laser Systems (UroFiber 150Q)

Rhein Laser Technologies Co., Ltd. · Jul 21, 2026 · K261738

FDA cleared the Medical Thulium Fiber Laser Systems (UroFiber 150Q) from Rhein Laser Technologies Co., Ltd. on Jul 21, 2026 under K261738, 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 May 27, 2026. The decision came 55 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Rhein Laser Technologies Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261738?

K261738 is the FDA 510(k) for Medical Thulium Fiber Laser Systems (UroFiber 150Q), submitted by Rhein Laser Technologies Co., Ltd.. FDA's decision date was Jul 21, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Medical Thulium Fiber Laser Systems (UroFiber 150Q)?

Rhein Laser Technologies Co., Ltd., based in Wuhan, is the applicant of record for K261738.

How long did the K261738 review take?

FDA received the submission on May 27, 2026 and issued its decision on Jul 21, 2026, 55 days later.

← All decisions in July 2026