Applied Biophotonics , Ltd.

Applied Biophotonics, Ltd. specializes in phototherapy systems, specifically infrared and red-light units. Their devices include non-wearable musculoskeletal infrared phototherapy units and professional-grade red-light phototherapy systems. These are designed for therapeutic use, such as tissue repair and pain management, and are intended for clinical or professional settings.

Applied Biophotonics, Ltd. is based in the United States. Their devices are regulated in the U.S. under FDA guidelines, where they fall under the jurisdiction of the Food and Drug Administration’s classification system.

The devices produced by Applied Biophotonics, Ltd. 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 phototherapy systems used for therapeutic purposes.

Yes, the devices from Applied Biophotonics, Ltd. are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries help track and identify medical devices that have undergone the required regulatory processes for market authorization in the U.S.