Rhein Laser Announces FDA 510(k) Clearance of UroFiber 60Q

The Most Powerful Thulium SuperPulsed Fiber Laser for Urology is Here

WUHAN, China, Dec. 4, 2024 /PRNewswire/ -- Rhein Laser Technologies Co., Ltd. is proud to announce that its UroFiber^® 60Q SuperPulsed Thulium Fiber Laser System received FDA 510(k) clearance (K242293) on November 19, 2024, marking a significant breakthrough in surgical laser development. This certification makes Rhein Laser the first Chinese company to gain FDA clearance for a thulium fiber laser, demonstrating that its products meet the highest global standards set by the U.S. FDA, further reinforcing the company's leadership in medical laser technology.

UroFiber 60Q offers clear technological advantages. Compared to other fiber lasers, it delivers 20% higher laser peak power and 15% higher average output laser power, significantly enhancing performance, precision, and treatment speed. In laser lithotripsy, its increased power allows for rapid stone fragmentation, reducing treatment time and minimizing collateral damage, leading to faster patient recovery. In soft tissue treatments, the laser's precision reduces bleeding, minimizes thermal damage, and shortens recovery time, offering a safer, more effective treatment experience for patients.

The FDA clearance of UroFiber 60Q not only validates its safety and effectiveness but also opens up new opportunities for Rhein Laser to expand its reach in the U.S. and global markets. As the first Chinese company to achieve FDA clearance for thulium fiber laser technology, Rhein Laser is poised to bring its innovative solutions to a wider audience and continue driving advancements in medical treatments worldwide.

In addition, Rhein Laser is advancing further with the UroFiber 150Q, a powerful water-cooled system for which FDA clearance has already been submitted. UroFiber 150Q features 10J single-laser pulse energy with 200um application fiber, a 15Hz repetition frequency, and 150W maximum pulse output laser power, making it the most powerful SuperPulsed thulium fiber laser available. With these advanced specifications, UroFiber 150Q will offer even faster, more effective treatments, positioning it as the future leader in urological laser therapy.

"We have strong R&D teams based in Duesseldorf and in Wuhan of China's Optics Valley, combining Germany's precision with China's innovative efficiency, which allows us to continuously push the boundaries of laser technology," said Dr. Lin Yang, CEO of Rhein Laser. "Our goal is to provide world-class medical laser solutions and improve patient outcomes globally."

With FDA certification and cutting-edge technology, UroFiber 60Q is set to lead the future of urological laser treatments, delivering enhanced safety, precision, and patient care that will transform medical practices worldwide.

For more information
Visit www.UroFiber.com for more details about the UroFiber laser system.

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