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

    PBM Hair Therapy Cap

    K Number: K240472 · Decision Oct 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    234

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    Basic Information

    Device Name
    PBM Hair Therapy Cap
    K Number
    K240472
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan Tutamen Metalwork Co., Ltd.
    Date Received
    February 20, 2024
    Decision Date
    October 11, 2024
    Product Code
    OAP
    Advisory Committee
    Physical Medicine
    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
    OAP Laser, Comb, Hair

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    Other Clearances by Dongguan Tutamen Metalwork Co., Ltd.

    K Number Device Name
    K252439 Tutamen Self Adhesive Electrodes