Device Dossier

Carewear Firefly Controller - Red/blue light phototherapy unit

Device Dossier for Carewear Firefly Controller - Red/blue light phototherapy unit (Red/blue light phototherapy unit, Class IIa, sponsor Vicki Partridge).…

Intended purpose

The device is intended to be used for Photobiomodulation (PBM) therapy application. The device is intended to emit optical power in the blue or blue and red spectra using non-coherent light emitting diodes (LEDs) and thermal conduction to treat pain, relieve stiffness in muscles and joints, accelerate recovery from exercise and soft tissue injury, treat facial skin conditions and skin rejuvenation. This device consists of flexible light patches powered by a rechargeable wireless controller and a coupling gel pad. This is a single patient reusable device.

TGA Public Summary