Advalight Aps

Advalight Aps specializes in dermatological frequency-doubled solid-state laser systems. These devices are engineered for skin treatments, including hair removal, pigmentation correction, and vascular lesion treatment. The technology relies on precise laser wavelengths to safely and effectively target specific skin conditions.

Advalight Aps is headquartered in the United States. The company’s location is relevant for regulatory compliance and customer support, as it aligns with FDA oversight for its Class II devices.

Advalight Aps’s devices are included in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) database. These registries ensure traceability and compliance with U.S. medical device regulations, particularly for Class II devices.

Advalight Aps’s dermatological laser systems fall under FDA Class II classification. This classification applies to devices posing moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.