BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Tomey Optical Biometer OA-2000 (OA-2000)

    K Number: K252348 · Decision Dec 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    22
    Applicant Total
    5
    Review Days
    142

    Basic Information

    Device Name
    Tomey Optical Biometer OA-2000 (OA-2000)
    K Number
    K252348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tomey Corporation
    Date Received
    July 29, 2025
    Decision Date
    December 18, 2025
    Product Code
    MXK
    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
    MXK Device, Analysis, Anterior Segment

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