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510(k) Data Aggregation

    K Number
    K210948
    Device Name
    Omnilux CLEAR
    Manufacturer
    GlobalMed Technologies
    Date Cleared
    2021-06-24

    (86 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    GlobalMed Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Omnilux CLEAR acne facemask 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 on the face.
    Device Description
    The Omnilux CLEAR consists of: 1. Silicon flexible face mask 2. Controller 3. Power supply and country specific adaptors 4. USB C to USB A connector 5. 2 x Velcro Straps The Omnilux CLEAR acne facemask 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 on the face. The system consists of a flexible silicon mask (1) that contains light emitting diodes (LEDs) and a controller (2). The LEDs generate the light. The mask is worn on the face and is held in place by two adjustable Velcro straps (5). The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of medical grade silicon. The controller (2) 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 (3) 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 (4). The Omnilux CLEAR mask 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.
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