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

    UNITY VCS (8065000296); UNITY CS (8065000297)

    K Number: K233876 · Decision Jun 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    311
    Applicant Total
    3
    Review Days
    197

    Basic Information

    Device Name
    UNITY VCS (8065000296); UNITY CS (8065000297)
    K Number
    K233876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Laboratories Inc.
    Date Received
    December 7, 2023
    Decision Date
    June 21, 2024
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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