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

    UniVit HE, UniVit UHS

    K Number: K212763 · Decision Aug 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    1
    Review Days
    344

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    Basic Information

    Device Name
    UniVit HE, UniVit UHS
    K Number
    K212763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visioncare Devices, LLC
    Date Received
    August 31, 2021
    Decision Date
    August 10, 2022
    Product Code
    HQE
    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
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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