DEVICE: VISIONIX (03664188000909)

Device Identifier (DI) Information

VISIONIX
VX130
In Commercial Distribution

LUNEAU TECHNOLOGY OPERATIONS
03664188000909
GS1

1
260432380 *Terms of Use
The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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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?
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.
Active false
45721 Optical pachymeter
A mains electricity (AC-powered), ophthalmic, device that uses optics to measure the thickness of the cornea. Using optical low coherence reflectometry (OLCR) this device can possibly measure corneal thicknesses to a precision of one micron without having to make contact with the eye surface and no contact fluids are required, nor will it induce any indentation. This device, also known as a pachometer, will provide data that is used to evaluate the results of eye surgery [e.g., laser assisted in situ keratomileusis (LASIK) treatment], monitor epithelium regrowth, and for other ophthalmic measurement evaluations.
Obsolete false
16809 Ophthalmic tonometer, battery-operated
An ophthalmic, battery-powered, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force against the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This hand-held device (known as a contact type, e.g., a Perkins tonometer) is often used for, e.g., the examination of postoperative, bedridden and paediatric patients.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
HKX Tonometer, Ac-Powered
HKO Refractometer, Ophthalmic
MXK Device,Analysis,Anterior Segment
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FDA Premarket Submission

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Premarket Submission Number Not Available/Not Released
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Sterilization

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Storage and Handling

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Clinically Relevant Size

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Device Record Status

a06715ef-136a-41eb-9b3b-30a2d01b7a69
January 15, 2025
7
May 25, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package 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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