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510(k) Data Aggregation
K Number
K133062Device Name
DISCOVERY SYSTEM
Manufacturer
Date Cleared
2014-06-20
(266 days)
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
INNOVATIVE VISUAL SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Discovery System is intended for use in:
-Mapping the lower and higher order aberrations of the eye which includes measurement of the spherical power, cylindrical power and cylinder axis.
-The measurement and analysis of corneal curvature (comeal refractive power, and cylinder axis of the cornea. The device also maps the display of the corneal shape.
- White-to-white measurements (also called WTW or horizontal corneal diameter).
-Retro-illumination imaging of the anterior segment of the eye including intraocular lens imaging.
- The measurement of pupil diameter.
-In the automated measurement and analysis of refractive errors of the eye including hyperopia and myopia from -25.0 to +15.0 diopters spherical, and astigmatism from 0.0 to ± 10.0 diopters.
Device Description
The Discovery System combines a corneal topographer and an ocular wavefront aberrometer into a single, efficient system. The Discovery System combines several features to provide clinicians with detailed ophthalmic measurements. The Discovery System is designed to quickly and easily capture:
- Anterior corneal topography .
- Ocular wavefront aberrations .
- Retro-illumination images .
- Iris images .
Using near infrared (NIR) light sources for both the corneal topography and ocular wavefront aberrations permits these measurements to be taken simultaneously along the same optical axis. Retro-illuminated imaging is provided using a NIR light source reflected off the retina and optional white light and/or NIR anterior eye light sources. Iris images are captured during a retro-illumination acquisition and can optionally be captured during all other exam type acquisitions to identify eye rotations between examinations.
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