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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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    K Number
    K131338
    Device Name
    DERMA HOOD
    Manufacturer
    GLOBALMEDIA GROUP, LLC
    Date Cleared
    2013-07-10

    (62 days)

    Product Code
    PEQ
    Regulation Number
    880.6320
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBALMEDIA GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses. The Derma Hood accessory is designed for use within healthcare facilities (Doctor's offices, clinics, hospitals, etc.).
    Device Description
    The Derma Hood is an accessory for the TotalExam HD Examination Light. The Derma Hood utilizes standard off-the-shelf light filters and lenses.
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    K Number
    K130624
    Device Name
    CONI
    Manufacturer
    GLOBALMED
    Date Cleared
    2013-05-07

    (60 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBALMED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection. CONi is not intended for use in mammography. CONi is not intended for diagnostic use on mobile devices
    Device Description
    CONi (Capture Over Network Interface) is a secure cloud-based application for viewing and archiving medical images. The CONi software system is comprised of a Picture Archiving and Communication System (CONiPACS) and an image viewer (CONiView). CONi supports imaging studies from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.
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