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510(k) Data Aggregation
K Number
K023249Device Name
ALCON LADARWAVE CUSTOMCORNEA WAVEFRONT SYSTEM
Manufacturer
ALCON LABORATORIES, INC.
Date Cleared
2002-10-18
(18 days)
Product Code
NCF
Regulation Number
886.1760Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LADARWave" CustomCornea® Wavefront System is used for measuring, recording, and analyzing visual aberrations (such as myopia, hyperopia, astigmatism, coma and spherical aberration) and for displaying refractive error maps of the eye to assist in prescribing refractive corrections. This device is enabled to export wavefront data and associated anatomical registration information to a compatible treatment laser with an indication for wavefront-guided refractive surgery.
Device Description
The LADARWave" CustomCornea® Wavefront System is an aberrometer, utilizing Hartmann-Shack wavefront sensing to measure the aberrations in the human eye. The device contains four major optical subsystems used in the clinical wavefront examination: a fixation subsystem, a video subsystem, a probe beam subsystem, and a wavefront detection subsystem. These subsystems are all under control of the device software.
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