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

    KALA MINI 2.0 (KALA-04)

    K Number: K251781 · Decision Sep 4, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    23
    Review Days
    85

    Basic Information

    Device Name
    KALA MINI 2.0 (KALA-04)
    K Number
    K251781
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Received
    June 11, 2025
    Decision Date
    September 4, 2025
    Product Code
    OHS
    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
    OHS Light Based Over The Counter Wrinkle Reduction

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