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510(k) Data Aggregation

    K Number
    K230076
    Device Name
    Enhanced AURORA™ Medical Diode System, and related accessories
    Manufacturer
    Psoria-Shield, Inc.
    Date Cleared
    2023-03-08

    (57 days)

    Product Code
    FTC, GEX
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Psoria-Shield, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
    Device Description
    The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area. The device is comprised of four main components: - A base station - A touchscreen where the user can enter system commands - Two handpieces connected to the base by power cables. One handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece. - A printer accessory that can print out verification of treatment parameters for hard copy records.
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    K Number
    K192411
    Device Name
    Psoria-Shield AURORA
    Manufacturer
    Psoria-Shield
    Date Cleared
    2020-07-02

    (302 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Psoria-Shield

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AURORA system is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
    Device Description
    The Psoria-Shield AURORA system delivers UVA or UVB phototherapy to target skin areas through one of two handpieces. The handpieces are connected to a base unit which uses an air cooling system to maintain system temperature, and has a built-in touchscreen to operate the device.
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    K Number
    K103540
    Device Name
    PSORIA-LIGHT
    Manufacturer
    PSORIA-SHIELD INC.
    Date Cleared
    2011-02-10

    (70 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSORIA-SHIELD INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Psoria-Light Model PS1000 is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
    Device Description
    Psoria-Light™ Model PS1000 delivers targeted ultraviolet (UV) light to small regions of affected skin (2.88 cm), sparring healthy skin. The system is capable of delivering either UVB light (300 to 320nm) or UVA light (350 to 395nm). Psoria-Light™ Model PS1000 generates both UVA and UVB light via LED technology, avoiding environmental concerns associated with disposal and exchange of mercury gas lamps, Xenon, and Chlorine gases commonly associated with targeted UV phototherapy devices. Psoria-Light's™ UVB LEDs emit light between 300 and 320 nm, avoiding light emissions below 300nm. Psoria-Light™ Model PS1000 incorporates a unique safety feature, a non-contact sensor located about the aperture of the handpiece that detects human skin. The trigger mechanism for UV dosage administration (located on the handpiece) is disabled until a suitable surface is detected by this sensor.
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