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The MZ Skin LightMAX Supercharged LED Mask 2.0 is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The MZ Skin LightMAX Supercharged LED Mask 2.0 is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.

The MZ Skin LightMAX Supercharged LED Mask 2.0 (LightMAX) is a home use wearable light emitting diode (LED) phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles and mild to moderate acne vulgaris of the face. The system consists of a flexible silicon mask and a controller. The flexible silicon mask is manufactured from (Genvan GA 3-9) and contains the light emitting diodes (LEDs) The LEDs generate the light. The mask is worn on the face and is held in place by adjustable Velcro straps. The LEDs produce blue, red and near infra-red (NIR) light in the visible spectrum (Blue: 412.5nm +/- 7.5nm, Red: 630nm +/- 10nm, NIR 830nm +/-15nm.). The device works through non-thermal mechanisms called Photobiomodulation (wrinkles) and endogenous Photodynamic therapy (acne vulgaris). The controller (ABSKF757 / Polyac-757) allows the user to select one of two treatment programmes (acne or wrinkles) and switches the LEDs ON/OFF, controlling power to the mask. The programs are selected by the user pressing and holding the appropriate power button. The controller contains a countdown timer that activates once the user has selected the appropriate treatment program and counts down from 10:00 minutes. The user may stop the treatment program during the 10 minutes by pressing the appropriate ON/OFF button. The controller contains a rechargeable Lithium-ion polymer battery. The controller uses a visible display comprising of 3 micro-LEDs to show the user the battery charge status of the device. The power supply (SK01T-0500100Z) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin (3) input socket and wall plug. The power cable is connected to the controller by a standard micro-USB A-C connector. The MZ Skin LightMAX Supercharged LED Mask 2.0 cannot be operated while charging. The mask compromises of 2 surfaces. An inner clear surface that contacts the skin and an outer surface. Both surfaces are constructed of the same silicone (Methyl vinyl silicone rubber GENVAN GA 3 series GA9 series). The inner surface contacts with the user's skin. Contact is restricted to normal intact skin and only for a duration of 10 minutes (treatment time). Methyl vinyl silicone rubber Genvan GA 3 series GA9 series has been tested to those tests specified under ISO 10993-5:2009 tests for in vitro cytotoxicity and ISO10993-10:2010 Tests for irritation and skin sensitization. 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.