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

    Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

    K Number: K260129 · Decision Apr 15, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    32
    Applicant Total
    23
    Review Days
    89

    Basic Information

    Device Name
    Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )
    K Number
    K260129
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Received
    January 16, 2026
    Decision Date
    April 15, 2026
    Product Code
    OLI
    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
    OLI Fat Reducing Low Level Laser

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