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

    ISL QC 2000

    K Number: K892058 · Decision Jun 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    78

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    Basic Information

    Device Name
    ISL QC 2000
    K Number
    K892058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4392
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Intelligent Surgical Lasers, Inc.
    Date Received
    March 29, 1989
    Decision Date
    June 15, 1989
    Product Code
    LXS
    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
    LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

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    Other Clearances by Intelligent Surgical Lasers, Inc.

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