Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K191086
    Device Name
    Exciplex
    Manufacturer
    Clarteis
    Date Cleared
    2019-12-11

    (231 days)

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

    Clarteis

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The exciplex® is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The reusable polycarbonate/ABS reduction tips and reusable silicone masks are for use on intact skin only.
    Device Description
    The Exciplex is a compact handheld excimer device that emits a narrow-band UVB light at 308 nm. This ultraviolet wavelength of light is known to be beneficial in the treatment of various dermatological conditions such as psoriasis and vitiligo. The UVB light is homogeneously delivered through a 5x5 cm² output window at an irradiance of 100 mW/cm². Treatments are performed by applying the output window over the affected area with the help of reduction tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light pulses where the device is used multiple times along the affected area.
    Ask a Question
    K Number
    K171702
    Device Name
    Exciplex308nm
    Manufacturer
    Clarteis
    Date Cleared
    2017-10-13

    (127 days)

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

    Clarteis

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
    Device Description
    The Exciplex 308m" is a compact handheld excimer device that emits a narrow-band UVB light at 308nm. This ultraviolet wavelength of light is known to be beneficial in the treatment of various dermatological conditions such as psoriasis and vitiligo. The UVB light is homogeneously delivered through a 5x5cm² output window at an irradiance of 100mW/cm². Treatments are performed by applying the output window over the affected area with the help of treatment tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light "shots" where the device is used multiple times along the affected area.
    Ask a Question

    Page 1 of 1