Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

The company specializes in electrohydraulic lithotripsy systems, which are used primarily for breaking up kidney or urinary stones. Their product line includes electrohydraulic lithotripsy probes (such as EHL Probe variants), lithotriptors (like the Electrohydraulic Lithotriptor TCS-B3-II), and associated laser therapeutic devices. This includes holmium and thulium fiber laser systems (e.g., Holmium Laser System Potent HP90/HP100 and Thulium Fiber Laser System TFL-A/B) as well as laser fibers for medical procedures. These devices are designed for minimally invasive treatments in urology.

The company operates from the United States. While its name suggests a Guangzhou origin, its manufacturing and regulatory presence is established in the US market, where its devices are developed and distributed.

The company’s devices are included in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the necessary regulatory pathways to demonstrate substantial equivalence to legally marketed predicate devices, ensuring compliance with US regulatory requirements.

The company’s devices fall under Class II classification in regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. Examples include lithotripsy systems and laser therapeutic apparatuses, which require validation of performance, labeling, and manufacturing processes to mitigate risks like improper use or device malfunction.