AccessGUDID - DEVICE: Visionix (03664188000060)

GUDID

Device Identifier (DI) Information

Brand Name: Visionix
Version or Model: VX110
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LUNEAU TECHNOLOGY OPERATIONS

Primary DI Number: 03664188000060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 260432380 *Terms of Use

Device Description: The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminator, 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 cornea.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
13236	Pupillometer, electrically-powered	An electrically-powered ophthalmic instrument intended to be used for measuring the width or diameter of the pupil. The patient will, e.g., view into this device and the operator will see the pupil and its shape.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKO	Refractometer, Ophthalmic
MXK	Device, Analysis, Anterior Segment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 14180ca2-32a6-45fc-ac32-7ab3fa7a50ff
Public Version Date: January 15, 2025
Public Version Number: 2
DI Record Publish Date: June 08, 2023