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

    Katalyst Cyclophotocoagulation Probe

    K Number: K163632 · Decision Jun 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    7
    Review Days
    175

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    Basic Information

    Device Name
    Katalyst Cyclophotocoagulation Probe
    K Number
    K163632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Katalyst Surgical, LLC
    Date Received
    December 22, 2016
    Decision Date
    June 15, 2017
    Product Code
    LQJ
    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
    LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser

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