DEVICE: REFRACTIVE POWER / CORNEAL ANALYZER (04987669100776)
Device Identifier (DI) Information
REFRACTIVE POWER / CORNEAL ANALYZER
OPD-Scan III
In Commercial Distribution
NIDEK CO.,LTD.
OPD-Scan III
In Commercial Distribution
NIDEK CO.,LTD.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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18038 | 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.
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Active | false |
16347 | Keratoscope, powered |
An electrically-powered ophthalmic device intended for qualitative assessment of the curvature of the anterior surface of the cornea, typically to detect astigmatism during ophthalmic surgery; it is not a keratometer. It may be designed as a hand-held instrument or to be mounted on a device (e.g., on an ophthalmic surgical microscope) and emits concentric rings of light onto the corneal surface (similar to a Placido disk) whereby the distorted reflection of the light rings on the cornea of the patient is indicative of astigmatism. This is a reusable device.
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Active | false |
36386 | Automated ophthalmic refractometer |
An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HLQ | Keratoscope, Ac-Powered |
HKO | Refractometer, Ophthalmic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
f3db53c8-57a9-4fb1-bcea-3d84c48fedcd
December 21, 2020
5
August 19, 2016
December 21, 2020
5
August 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-223-9044
info@nidek.com
info@nidek.com