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510(k) Data Aggregation
K Number
K043503Device Name
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
Manufacturer
VISX, INCORPORATED
Date Cleared
2005-04-05
(106 days)
Product Code
HJO
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
VISX, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic illumination device intended for use to inspect the structures of the anterior segment of the eye.
Device Description
The VISX CV SI-1 CustomVue Slit Illuminator consists of the slit illuminator and a charger unit. The charger unit serves both as a continuous charger as well as a convenient base for the instrument. The slit illumination is focused onto the corneal surface, which is observed through the operating microscope (or the surgeon may also alter the angle of the slit illumination). The length and width of the slit may be altered by the surgeon. The slit illuminator allows the control of slit width to enhance observation of structural detail. The slit illuminator allows control of slit width from 0 to 10.0 mm via means of sliding control knobs.
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K Number
K000327Device Name
WAVESCAN WAVEFRONT SYSTEM MODEL HS 1
Manufacturer
VISX, INCORPORATED
Date Cleared
2000-05-02
(90 days)
Product Code
HKO
Regulation Number
886.1760Why did this record match?
Applicant Name (Manufacturer) :
VISX, INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VISX WaveScan™ Wavefront System is a diagnostic instrument indicated for the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from +6.00 to -8.00 diopters spherical, and astigmatism from 0.00 to -6.00 diopters.
Device Description
The WaveScan™ Wavefront System Model HS 1 autorefractor device is a diagnostic instrument designed to measure refractive error of the eye automatically by use of wavefront technology. Light travels in a procession of flat sheets known as wavefronts. As these wavefronts pass through an imperfect refractive medium including the cornea and the lens, the aberrations which are created by the irregular surfaces "wrinkle" the light rays and create wavefront errors or distortions. The instrument contains tiny sensors which measure the gradient, or slope, of the wavefront which emanate from the eye. After light travels through the eye's optical system and out again, the sensors accurately detect slight variations of wavefront irregularities as they exit the eye. The sensors then provide additional information within the confines of the instrument through a series of lenses and apertures which are subject to mathematical algorithms and software. Once analyzed by the computer, a refractive error read-out is provided to the user. This analysis is made from multiple points of light which precisely pinpoint variations in refractive status across the entrance pupil of the eye. This allows for the high level of accuracy of the instrument thus providing the user with very precise readings of refractive error.
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