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510(k) Data Aggregation

    K Number
    K233295
    Device Name
    LFR-260
    Date Cleared
    2024-05-31

    (245 days)

    Product Code
    Regulation Number
    886.1770
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    Product Code :

    SBI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LFR-260 is a portable manual refractor providing capabilities to the eyecare provider to perform distance vision testing and subjectively measure sphere, cylinder and axis refractive errors in patients aged from 12-65 years old with healthy visual systems. The device measures spherical error in the range of -10 to +15D and measures cylinder error within +/- 2.5D.
    Device Description
    The LFR-260 is a portable digital refractor which allows for determination of refractive error as well as for fully remote refractions. The LFR-260 achieves the similar functionality as Comprehensive Phoropter, MDR-680, which is a standard refractor, but relies on the use of a micro lens array, a highdensity embedded display, and a tunable lens. The reduced number of lenses allows for higher portability and a smaller footprint.
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