DEVICE: VISIONIX (03664188000039)
Device Identifier (DI) Information
VISIONIX
VX130+
In Commercial Distribution
LUNEAU TECHNOLOGY OPERATIONS
VX130+
In Commercial Distribution
LUNEAU TECHNOLOGY OPERATIONS
The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefractometer, keratometer, corneal topographer, tonometer, multi-slit pachymeter, tear-film analyzer , and retro illumination.
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
Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT)
Meibomian glands imaging
Evaluation of tear meniscus height
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? |
|---|---|---|---|---|
| 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 |
| 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.
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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.
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Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HKX | Tonometer, Ac-Powered |
| HKO | Refractometer, Ophthalmic |
| MXK | Device,Analysis,Anterior Segment |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
ebcf8da6-c223-4c98-992a-1047b12299f5
January 15, 2025
7
May 25, 2020
January 15, 2025
7
May 25, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined