BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SPECCHIO

    K Number: K260647 · Decision Apr 2, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    77
    Applicant Total
    15
    Review Days
    34

    Basic Information

    Device Name
    SPECCHIO
    K Number
    K260647
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    El.En S.P.A.
    Date Received
    February 27, 2026
    Decision Date
    April 2, 2026
    Product Code
    PBX
    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
    PBX Massager, Vacuum, Radio Frequency Induced Heat

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