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510(k) Data Aggregation

    K Number
    K223882
    Device Name
    Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)
    Manufacturer
    Shenzhen Honpal Optoelectronic Technology Co., Ltd.
    Date Cleared
    2023-03-27

    (90 days)

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

    Shenzhen Honpal Optoelectronic Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Narrowband UV Phototherapy Light Lamp is intended for use, by or under the direction of a physician for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use on all skin types (I-VI). It can be used in hospitals, clinics and households.
    Device Description
    The proposed device, Narrowband UV Phototherapy Light Lamp is a portable medical device that consists of LED lamp, irradiator, control circuit. It is a therapeutic product under the direction of a physician for individuals who require ultraviolet radiation for diagnosed skin disorders. It is for the partial treatment excluding eyes. Irradiation time can be adjusted from 0~299s and the treatment status can be controlled by the button on the device. The light comb equipped on the device is intended for easier treatment of target skin covered by hair, such as the scalp. The device is available in two models: model HB-UPLL-01and model HB-UPLL-02. The device can be used in hospitals, clinics and households.
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