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

    UV PHOTOTHERAPY

    K Number: K132643 · Decision Jan 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    271
    Applicant Total
    8
    Review Days
    157

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    Basic Information

    Device Name
    UV PHOTOTHERAPY
    K Number
    K132643
    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
    August 26, 2013
    Decision Date
    January 30, 2014
    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
    K242977 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)
    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