Enlight Medical Technologies (Shenzhen) Co., Ltd.

Enlight Medical Technologies specializes in neurovascular embolization coils, which are used primarily for treating cerebral aneurysms. These coils are designed to block blood flow into aneurysms, promoting clot formation and stabilizing the vessel. The company also produces neurovascular guidewires, which assist in navigating blood vessels during embolization procedures. These devices are tailored for precision deployment in neurovascular interventions.

Enlight Medical Technologies is based in the United States. The company’s primary focus is developing neurovascular embolization coils, including detachable and pushable variants, as well as neurovascular guidewires. These products are specifically designed for cerebral aneurysm treatment, addressing critical needs in vascular interventions.

Enlight Medical Technologies’ devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track medical devices that have undergone the necessary regulatory processes to demonstrate substantial equivalence to legally marketed predicate devices, ensuring compliance with FDA requirements for Class II devices.

Enlight Medical Technologies’ devices are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. Class II devices typically require premarket notification (510(k)) clearance to demonstrate they are substantially equivalent to a legally marketed predicate device.