Viax Dental Lab

Viax Dental Lab specializes in dental devices. Their primary product is the LUCERNA Dental Laser, which is used for procedures like soft tissue treatment, cavity detection, and gum reshaping. This device is tailored specifically for dental applications, ensuring precision and safety in oral healthcare settings.

Viax Dental Lab is headquartered in the United States. Being based there allows the company to align with U.S. regulatory standards and market its devices domestically, though their products may also be used internationally depending on local compliance requirements.

The LUCERNA Dental Laser, Viax Dental Lab’s main device, is classified as a Class II medical device. This classification is determined by the U.S. Food and Drug Administration (FDA) based on the device’s intended use and risk level. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness.

The LUCERNA Dental Laser is listed under the FDA’s 510(k) pathway, which is a premarket submission required for most Class II devices. This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, helping to establish its compliance with U.S. regulations. The device’s listing in this registry reflects its regulatory status in the United States.