Shenzhen Vivolight Medical Device & Technology Co., Ltd.

Shenzhen Vivolight specializes in two primary categories of medical devices: infrared-light vein locators, such as the VEINCAS, which help healthcare professionals identify veins during procedures, and intravascular imaging systems. These include the Cornaris Intravascular Imaging System (available in P80-E and Mobile-E variants) and the LumenCross Imaging Catheter (F2), which provide real-time visualization of blood vessels for precise interventions.

The company is headquartered in Shenzhen, China. While its operations are based there, its devices are listed for use in the US market, indicating regulatory compliance with US requirements for medical devices.

Shenzhen Vivolight’s devices are recorded in the FDA 510(k) and UDI registries. The 510(k) submission is used for Class II devices to demonstrate substantial equivalence to a predicate device, while the UDI system ensures unique identification and traceability of medical devices throughout their lifecycle, improving patient safety and regulatory oversight.

Shenzhen Vivolight’s devices fall under Class I and Class II classifications in the US. Class I devices are generally low-risk, like some infrared vein locators, and typically require only general controls for regulation. Class II devices, such as intravascular imaging systems, involve moderate risk and require special controls to ensure safety and effectiveness, often involving pre-market submissions like 510(k)s.