FDA.reportPublic FDA data

VISIONIX

Primary DI
03664188002200
Brand
VISIONIX
Company
LUNEAU TECHNOLOGY OPERATIONS
Model
VX220
Device description
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
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKXTonometer, Ac-Powered
MXKDevice,Analysis,Anterior Segment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKXTonometer, Ac-PoweredOphthalmic2
MXKDevice, Analysis, Anterior SegmentOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664188002200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664188002200036641880022003664188002200

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, battery-operatedAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260432380
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664188000060VisionixVX1102023-06-08
03664188000145Visionix VX650VX650100058442023-06-08
03664188000602VISIONIXVX40 Pro2025-09-05
03664188000589ZEISSVISUREF 10002025-03-11
03664188000138LuneauTonometer separation prisms L900 -box of 202023-06-08
03664188000077VISIONIXVX652025-01-02
03664188000169VISIONIXVX902025-01-02
03664188000312LuneauL12 Aesthesiometer2025-01-02
03664188000435ESSILORRetina 800RET1IN2025-01-02
03664188000558ESSILORWAM 700+2025-01-02
03664188000565ESSILORWAM 8002025-01-02
03664188000411VisionixVX6102024-04-30
03664188000084VisionixEyeRefract2023-06-15
03664188000008VisionixVX70 2x2023-06-08
03664188000015VisionixVX70 5x2023-06-08
03664188000091VisionixVX70 3x2023-06-08
03664188000152VisionixVX222023-06-08
03664188000176VisionixVX252023-06-08
03664188000220VisionixL2 Skiascopy racks2023-06-08
03664188000237VisionixVX22-NP2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003630624BOSSIntelon Optics, Inc.MXK2026-05-22
04719872711230MiiSMEDIMAGING INTEGRATED SOLUTION INC.HKX2026-04-29
04719876420046TonoVueCRYSTALVUE MEDICAL CORPORATIONHKX2026-04-15
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2026-03-31
06430033851920iCare ST500ICARE FINLAND OYHKX2025-12-05
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONMXK2025-11-17
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONHKX2025-11-17
07350023774307CalcibonBiomet Biologics, LLCHKX2025-10-09
00380659984372WaveLightAlcon Laboratories, Inc.MXK2025-03-12
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKX2025-03-11
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSHKX2025-01-02
06430033851784ST500 SmartCradleICARE FINLAND OYHKX2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKX2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKX2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKX2024-11-07
08034028770517ESSILORVISIA IMAGING SRLMXK2024-11-04
00851158007683Eli EzerU.S. OPHTHALMIC, L.L.C.HKX2024-01-25
08034028770487MYAHVISIA IMAGING SRLMXK2023-10-12
04547451026686INAMI INAMI & CO., LTD.HKX2023-07-27
04547451026709INAMIINAMI & CO., LTD.HKX2023-07-27
03615020000458WAVE ANALYZER MEDICA 800ESSILOR INTERNATIONALHKX2023-07-25
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKX2023-06-12
08800019600435Non-contact Tonometer HNT-1PHuvitz Co., Ltd.HKX2023-06-12
08800019600558Auto Tono/Refracto/Kerato/Pachymeter HTR-1AHuvitz Co., Ltd.HKX2023-06-12
03664188000060VisionixLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000145Visionix VX650LUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSHKX2023-06-08