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The faceLITE LED mask is an over the counter device that is intended for the use in the treatment of full-face wrinkles.

The faceLite consists of; 1. Silicon flexible face mask 2. Controller 3. Power supply and country specific adaptors 4. USB C to USB A connector 5. Head straps faceLite is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment cosmetic indications including facial wrinkles. The system consists of a flexible silicon mask that contains light emitting diodes (LEDs) and a controller. The LEDs generate the light. The mask is worn on the face and is held in place by an adjustable Velcro strap. The mask compromises of 2 surfaces. An inner 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 controller (Polycarbonate PC1100) switches the LEDs ON/OFF and controls power to the mask. 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 input socket and wall plug. The power cable is connected to the controller by a standard micro USB A-C connector. The faceLite cannot be operated while charging. 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. The faceLite Light emitting diode (LED) system emits light energy in the red and near infrared (NIR) region of the light spectrum and is intended to treat facial wrinkles through a nonthermal mechanism called Photobiomodulation.