BEUDAMED
    Product Code: SBI FDA class 1 21 CFR 886.1770

    Manual Refractor, 3d Display

    Ophthalmic

    A 3D display manual refractor is an optical ophthalmic device intended to measure the refractive error of the eye using a three-dimensional display interface, aiding eye care professionals in determining patients' corrective lens prescriptions. It is classified as FDA Class I (general controls) under regulation 886.1770 in the Ophthalmic specialty, with product code SBI, and does not require premarket notification (510(k)) to market. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    SBI
    Device Class
    FDA class 1
    Regulation Number
    886.1770
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A 3D Display Manual Refractor is an optical device intended to measure the refractive error of the eye.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K233295 LFR-260