VISIONIX - The VX220 is a multifunctional eye diagnostic - LUNEAU TECHNOLOGY OPERATIONS

Duns Number:260432380

Device Description: The VX220 is a multifunctional eye diagnostic device. There are several operation modes co The VX220 is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: keratometer, corneal topographer, tonometer,and pachymeter and retro illumination

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More Product Details

Catalog Number

-

Brand Name

VISIONIX

Version/Model Number

VX220

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

HKX

Product Code Name

Tonometer, Ac-Powered

Device Record Status

Public Device Record Key

0b5bbd5d-9177-491f-98bf-823adfa4fcdf

Public Version Date

May 15, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

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