Device Dossier

TheralumaX Red and Infrared Wearable and Handheld Phototherapy Devices - Red/infrared light phototherapy unit

Device Dossier for TheralumaX Red and Infrared Wearable and Handheld Phototherapy Devices - Red/infrared light phototherapy unit (Red/infrared light…

Intended purpose

The TheralumaX Red and Infrared Wearable and Handheld Phototherapy Devices are a family of non-invasive, externally applied, electrically powered active therapeutic medical devices that deliver visible red and near-infrared light energy to localised areas of the body. The family comprises devices in various configurations, including wearable devices, hand-held devices, flexible pads and mats designed for application to different areas of the body. The devices are intended for the temporary relief of musculoskeletal symptoms, including minor muscle and joint pain, muscle soreness and stiffness, to promote relaxation of muscle tissue, and to temporarily increase localised blood circulation. The devices are intended for external use only and are suitable for use in the home environment in accordance with the supplied Instructions for Use.