DEVICE: VISIONIX (03664188002200)

Device Identifier (DI) Information

VISIONIX
VX220
In Commercial Distribution

LUNEAU TECHNOLOGY OPERATIONS
03664188002200
GS1

1
260432380 *Terms of Use
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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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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GMDN

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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?
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.
Obsolete 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.
Obsolete false
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FDA Product Code

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Product Code Product Code Name
HKX Tonometer, Ac-Powered
MXK Device,Analysis,Anterior Segment
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FDA Premarket Submission

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

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No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0b5bbd5d-9177-491f-98bf-823adfa4fcdf
January 15, 2025
4
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
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Customer Contact

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No Customer Contact currently defined
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