FDA OKs Rhein Laser’s UroFiber 60Q SuperPulsed Thulium Fiber Laser

Rhein Laser Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its UroFiber 60Q SuperPulsed thulium fiber laser system. The certification makes Rhein Laser the first Chinese company to earn FDA clearance for a thulium fiber laser.

According to the company, UroFiber 60Q delivers 20% higher laser peak power and 15% higher average output laser power. In laser lithotripsy, its higher power provides rapid stone fragmentation, which reduces treatment time and minimizes collateral damage.

For soft tissue treatments, the laser’s precision can reduce bleeding, minimize thermal damage, and shorten recovery time.

Rhein Laser also said it’s submitted UroFiber 150Q, a powerful, water-cooled system, for FDA clearance. UroFiber 150Q touts 10J single-laser pulse energy with 200um application fiber, a 15Hz repetition frequency, and 150W maximum pulse output laser power. This makes it the most powerful SuperPulsed thulium fiber laser available, the company said.

“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.”