BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Ultraviolet Phototherapy Device

    K Number: K250425 · Decision Apr 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    5
    Review Days
    52

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    Basic Information

    Device Name
    Ultraviolet Phototherapy Device
    K Number
    K250425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    APK Technology Co., Ltd.
    Date Received
    February 14, 2025
    Decision Date
    April 7, 2025
    Product Code
    FTC
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FTC Light, Ultraviolet, Dermatological

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    Other Clearances by APK Technology Co., Ltd.

    K Number Device Name
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