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

    LOS 3D VISION 100

    K Number: K930965 · Decision Apr 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    3
    Review Days
    411

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    Basic Information

    Device Name
    LOS 3D VISION 100
    K Number
    K930965
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laser Optik Systeme GmbH & Co. KG
    Date Received
    February 24, 1993
    Decision Date
    April 11, 1994
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Laser Optik Systeme GmbH & Co. KG

    K Number Device Name
    K992540 XENON LIGHT SOURCE PES 1
    K953419 LOS 3D VISION 100