VISIONIX

Basic Information

• Brand Name: VISIONIX
• Primary DI: 03664188000909
• Version / Model: VX130
• Company Name: LUNEAU TECHNOLOGY OPERATIONS
• Labeler DUNS: 260432380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-25
• Public Version: 5
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: a06715ef-136a-41eb-9b3b-30a2d01b7a69

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKX	Tonometer, Ac-Powered	Ophthalmic	886.1930	2
HKO	Refractometer, Ophthalmic	Ophthalmic	886.1760	1
MXK	Device,Analysis,Anterior Segment	Ophthalmic	886.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Obsolete
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03664188000909	GS1

Premarket Submissions

Submission Number	Supplement Number
K162067	000