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The proposed intended use of the Lightfusion™ LED system is to emit energy in the RED and Near Infra-Red (NIR) regions of the spectrum and is indicated for the treatment of periorbital wrinkles.

The LIGHTFUSION™ LED system is a table top, portable phototherapy device whose purpose is to produce an even, cool, narrow-band of light for the treatment periorbital wrinkles. The system consists of a main body or controller that controls the 3 LED face pads. The controller switches the LEDs ON/OFF and controls power to the face pads. The controller contains a timer display consisting of a Dot matrix display. The controller contains software that monitors the face pad temperature via thermistors within the face pads contain the light emitting diodes (LEDs). The LEDs generate the light. The LEDs emit light energy in the red and near infrared light wavebands with peak wavelengths of 630nm +/-10nm, NIR: 830nm +/-17.5nm (Spectral range: Red 620-640nm, NIR 812.5-847.5nm). The therapy heads are designed to be placed over the forehead, sides of the face and chin. The power supply is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The power cable is connected to the controller by a standard coaxial connector. The face pads are connected to the controller by individual connectors that are sealed within the controller and cannot be removed by the user. The face pads contain a temperature sensor (thermistor) that feeds the temperature back to the controller. The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The equipment does not require checks on the light output as the LEDs do not dim with age to any practical extent. LIGHTFUSION Light emitting diode (LED) system emits light energy in the red and near infra-red (NIR) region of the light spectrum and is intended to treat periorbital wrinkles through a non-thermal mechanism of Photobiomodulation. Photobiomodulation is a form of light therapy that utilizes non ionizing forms of light sources such as LEDs, in the visible and near infrared spectrum. It is a non thermal process involving endogenous chromophores eliciting photophysical and photochemical events at various biological scales.