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510(k) K253039

Device
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
Applicant
Topcon Corporation
510(k) number
K253039
Product code
HKX
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-07
Date received
2025-09-22
Regulation
886.1930
Classification name
Tonometer, Ac-Powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Tomoka Nishiyama
Address
75-1 Hasunuma-Cho Itabashi-Ku Tokyo JP 174-8580 174-8580

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HKX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc.2023-11-08
K190382Intraocular Pressure Tonometer EASYTONCompany Elamed2019-12-06
K181260MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis)2019-06-21
K181143Keeler TonoCare TonometerKeeler Instruments, Inc.2019-02-08
K180820Tono Vue Non-Contact TonometerCrystalvue Medical Corporation2018-12-14
K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas2017-04-24
K143086VX120 Ophthalmic Diagnostic DeviceLuneau Sas2015-06-01
K113066CORVIS STOculus Optikgerate GmbH2012-11-08
K111710FULL AUTO TONOMETER MODEL TX-20Canon Inc. -Medical Equipment Group2011-09-20
K093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000Keeler Instruments, Inc.2010-12-10
K083377ACCUPENAccutome Ultrasound, Inc.2009-07-27
K073087NON-CONTACT TONOMETER, MODEL FT-1000Tomey Corporation2008-11-18
K081756OCULAR RESPONSE ANALYZERReichert, Inc.2008-08-07
K053444KOWA KT-800Kowa Co. , Ltd.2006-06-09
K060780TONOMETER DIATONRyazan State Instruments2006-04-06