Weber Medical GmbH

Weber Medical GmbH specializes in non-wearable infrared phototherapy units focused on musculoskeletal applications. Their primary product line includes laser-based devices like the Weberneedle and WEBERNEEDLE BASIC LASER, which are designed for targeted tissue treatment in medical settings.

Weber Medical GmbH operates with its headquarters in the United States. The company’s location is relevant for understanding its regulatory and operational framework, particularly in relation to FDA compliance and reporting.

Weber Medical GmbH’s devices are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) system. These registries track devices that have undergone the necessary regulatory pathways for market authorization in the U.S.

Weber Medical GmbH’s devices, such as the Weberneedle and WEBERNEEDLE BASIC LASER, fall under Class II classification. This classification is assigned based on their intended use and risk level, requiring specific regulatory controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.