BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun

    K Number: K191881 · Decision Oct 28, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    80
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
    K Number
    K191881
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kbl GmbH
    Date Received
    July 15, 2019
    Decision Date
    October 28, 2019
    Product Code
    LEJ
    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
    LEJ Booth, Sun Tan

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