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510(k) Data Aggregation
K Number
K233295Device Name
LFR-260
Manufacturer
Date Cleared
2024-05-31
(245 days)
Product Code
Regulation Number
886.1770Why did this record match?
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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