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

    Notal Vision Home Optical Coherence Tomography (OCT) System

    K Number: DEN230043 · Decision May 15, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    3
    Review Days
    343

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    Basic Information

    Device Name
    Notal Vision Home Optical Coherence Tomography (OCT) System
    K Number
    DEN230043
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    886.1600
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Applicant
    Notal Vision, Inc.
    Date Received
    June 7, 2023
    Decision Date
    May 15, 2024
    Product Code
    SAX
    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
    SAX Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device

    Other Clearances by Notal Vision, Inc.

    K Number Device Name
    K050350 THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP)
    K014044 MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)