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

    OCULASE 514 OPHTHALMIC ARGON LASER

    K Number: K833532 · Decision Feb 4, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    3
    Review Days
    116

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    Basic Information

    Device Name
    OCULASE 514 OPHTHALMIC ARGON LASER
    K Number
    K833532
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Lasermed Corp.
    Date Received
    October 11, 1983
    Decision Date
    February 4, 1984
    Product Code
    HQF
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQF Laser, Ophthalmic

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    Other Clearances by Lasermed Corp.

    K Number Device Name
    K843594 AIRVIT MODEL 8500
    K828583 LASERMED OCULASE ARGON LASER