BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Visibly Digital Acuity Product

    K Number: K220090 · Decision Aug 12, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    213

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    Basic Information

    Device Name
    Visibly Digital Acuity Product
    K Number
    K220090
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Visibly, Inc.
    Date Received
    January 11, 2022
    Decision Date
    August 12, 2022
    Product Code
    QTO
    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
    QTO Digital Visual Acuity Test