DEVICE: REFRACTIVE POWER / CORNEAL ANALYZER (04987669100776)

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Device Identifier (DI) Information

REFRACTIVE POWER / CORNEAL ANALYZER
OPD-Scan III

NIDEK CO.,LTD.
04987669100776
GS1
1
The NIDEK refractive power / corneal analyzer OPD-Scan III (hereafter referred to as “the device”) measures objective refractive error, corneal curvature, shape of the anterior corneal surface (topography), and pupil size of the patient’s eye, and analyzes wavefront aberration. The measured refractive error can be used for reference when prescribing corrective lenses such as glasses or contact lenses.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Corneal topography system An assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.
Keratoscope, line-powered A line-powered diagnostic ophthalmic instrument, typically hand-held, used in ophthalmic work for examining the corneal topography. The device consists of a specially designed round plate, with a concentric bore and concentric white and black rings (Placido disk). In case of astigmatism the mirror-image of the rings gives a distorted picture of the cornea of the patient being examined.
Ophthalmic refractometer, automated A mains electricity (AC-powered), automated, ophthalmic device designed to measure the refractive error of the eye (the inaccuracies of focusing of light upon the retina) by measuring how light is changed when it enters the patient's eye(s). A beam of light is emitted from the device into the patient's eye and reflected back out where it is detected and measured for sphere, cylinder and axis, as well as high order aberration measurements; typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Using this information, the device, also known as an aberrometer, will automatically calculate the lens prescription needed to correct the patient's vision.
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FDA Product Code

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Product Code Product Code Name
HLQ Keratoscope, Ac-Powered
HKO Refractometer, Ophthalmic
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 19, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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1-800-223-9044
info@nidek.com
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