BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM

    K Number: K955007 · Decision Jan 26, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    4
    Review Days
    86

    Basic Information

    Device Name
    APPLIED OPTRONICS MODEL AOC 5060 SURGFICAL DIODE LASER SYSTEM
    K Number
    K955007
    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
    APPLIED OPTRONICS CORP.
    Date Received
    November 1, 1995
    Decision Date
    January 26, 1996
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by APPLIED OPTRONICS CORP.

    K Number Device Name
    K961710 AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM
    K961705 AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM
    K955014 APPLIED OPTRONICS MODEL AOC 25 SURGICAL DIODE