VISIONIX - The VX130+ is a multifunctional eye diagnostic - LUNEAU TECHNOLOGY OPERATIONS

Duns Number:260432380

Device Description: The VX130+ is a multifunctional eye diagnostic device. There are several operation modes c 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, cornealtopographer, 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 ImageImage of the cornea relative to the irisAnalysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT)Meibomian glands imagingEvaluation of tear meniscus height

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More Product Details

Catalog Number

-

Brand Name

VISIONIX

Version/Model Number

VX130+

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HKO

Product Code Name

Refractometer, Ophthalmic

Device Record Status

Public Device Record Key

ebcf8da6-c223-4c98-992a-1047b12299f5

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

May 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUNEAU TECHNOLOGY OPERATIONS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 13