FDA.reportPublic FDA data

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

Primary DI
04571130283343
Brand
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
Company
TOPCON CORPORATION
Model
TRK-3
Published
2025-11-17
Public version status
New
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
04571130283343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04571130283343045711302833434571130283343

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer, professionalAn ophthalmic, electrically-powered device intended to be used by a healthcare professional to measure 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), typically for the diagnosis of glaucoma. It may have a light contact with the eye, have a bench-top or hand-held design, and use various techniques (e.g., the air-puff tonometer records deflections of the cornea from a puff of pressurized air).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690542881
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04562123288315SPECULAR MICROSCOPE SP-1PSP-1P2016-09-19
04560126269287MIRROR CHART MC-5S for COMPU VISION CV-5000MC-5S2025-12-09
04560126269188AUTO KERATO-REFRACTOMETER KR-1KR-12025-11-21
04560126269140AUTO KERATO-REFRACTOMETER KR-800KR-8002025-10-31
04560126269164AUTO REFRACTOMETER RM-800RM-8002025-10-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)3D OCT-12025-09-11
04571130283381AUTO KERATO-REFRACTOMETER KR-1KR-12025-06-19
04571130283404AUTO KERATO-REFRACTOMETER KR-800PAKR-800PA2025-05-12
04560126268662SightPilot NAVi Controller SNi-1 COMPU VISION CV-5000 REFRACTION SYSTEM ChronosSNi-12025-05-01
04560126268495SightPilot NAVi Controller SNi-1 for COMPU VISION CV-5000SNi-12025-02-27
04571130283367AUTO KERATO-REFRACTOMETER KR-800AKR-800A2025-04-15
04562123288179COMPUTERIZED TONOMETER CT-80CT-802016-09-19
04560126268532COMPU VISION CV-5000CV-50002025-02-27
04560126268549COMPU VISION CV-5000CV-50002025-02-27
045601262685701DIAL CONTROLLER KB-50SKB-50S2025-02-27
04560126268624POWER SUPPLY UNIT for CV-5000 (PC EXTERNAL TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04560126268648POWER SUPPLY UNIT for CV-5000 (BUILT-IN PC TYPE)POWER SUPPLY UNIT for CV-50002025-02-27
04571130282773REFRACTION SYSTEM ChronosChronos2024-08-01
04571130283350AUTO KERATO-REFRACTOMETER KR-800KR-8002024-05-09
04571130283374AUTO REFRACTOMETER RM-800RM-8002024-05-09

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
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
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000923RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08