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

    Vista Ophthalmics Vitrectomy Probe

    K Number: K220030 · Decision May 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    Vista Ophthalmics Vitrectomy Probe
    K Number
    K220030
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vista Ophthalmics, LLC
    Date Received
    January 5, 2022
    Decision Date
    May 4, 2022
    Product Code
    MLZ
    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
    MLZ Vitrectomy, Instrument Cutter

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