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The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the red and near-infrared spectrum and is intended for the use in the treatment of full-face wrinkles. The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the blue region of the light spectrum and is intended for the use in the treatment of mild to moderate acne vulgaris of the face.

KALA Red Light Face Mask is a home wearable light-emitting diode phototherapy device with three proven wavelengths of light 630nm Red light, 830nm Near infrared red light and 465nm blue light, all of these lights are known to treat wrinkles and mild to moderate acne vulgaris of the face. Among them, the device emits energy in red and near-infrared spectrum to treat full-face wrinkles, emits energy in the blue region of the light spectrum to treat mild to moderate acne vulgaris of the face. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by Head Straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of silicone. The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA Red Light Face Mask cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. Switch the controller ON and allow the mask to run for Red + NIR or Blue modes and 10- or 20-minutes treatment time program. The cable for connecting with the controller is detachable. The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.