Visaris D.O.O. Belgrade

Visaris D.O.O. specializes in ophthalmic devices, specifically the Visaris Vision® series (including Vision C, Vision U, Vision V, and Vision X) and the Visaris Avanse. These devices are designed for applications in eye care, such as diagnostic imaging or treatment, though the exact use cases are not detailed in the provided data.

Visaris D.O.O. is headquartered in Belgrade. While the company is based in Serbia, its regulatory submissions are filed in the United States, as indicated by the presence of its devices in the FDA’s 510(k) registry.

Visaris D.O.O.’s devices are listed in the FDA’s 510(k) registry because these products are classified as Class II devices under U.S. regulations. The 510(k) pathway is used for devices that are not significantly different from existing predicate devices, requiring manufacturers to demonstrate substantial equivalence to an already cleared device.

Visaris D.O.O.’s devices are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.