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

    308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)

    K Number: K242977 · Decision Feb 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    8
    Review Days
    133

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    Basic Information

    Device Name
    308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
    K Number
    K242977
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4630
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xuzhou Kernel Medical Equipment Co., Ltd.
    Date Received
    September 26, 2024
    Decision Date
    February 6, 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 Xuzhou Kernel Medical Equipment Co., Ltd.

    K Number Device Name
    K222751 LED Light Therapy Device, KN-7000L
    K200971 308nm Excimer System
    K200929 Hair Growth System
    K190685 Hair Growth System
    K181805 UV Phototherapy
    K160341 Colposcope System
    K132643 UV PHOTOTHERAPY