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HKX — Tonometer, Ac-Powered Class II

FDA Device Classification

Classification Details

Product Code
HKX
Device Class
Class II
Regulation Number
886.1930
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253039topcon corporationAUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIANovember 7, 2025
K223739medimaging integrated solutionVS Tabletop TonometerNovember 8, 2023
K190382company elamedIntraocular Pressure Tonometer EASYTONDecember 6, 2019
K181260medimaging integrated solution, inc (miis)MiiS Horus Scope DPT 100June 21, 2019
K181143keeler instrumentsKeeler TonoCare TonometerFebruary 8, 2019
K180820crystalvue medical corporationTono Vue Non-Contact TonometerDecember 14, 2018
K162067luneauVX130 Ophthalmic Diagnostic DeviceApril 24, 2017
K143086luneauVX120 Ophthalmic Diagnostic DeviceJune 1, 2015
K113066oculus optikgerateCORVIS STNovember 8, 2012
K111710canon inc. -medical equipment groupFULL AUTO TONOMETER MODEL TX-20September 20, 2011
K093298keeler instrumentsPULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000December 10, 2010
K083377accutome ultrasoundACCUPENJuly 27, 2009
K073087tomey corporationNON-CONTACT TONOMETER, MODEL FT-1000November 18, 2008
K081756reichertOCULAR RESPONSE ANALYZERAugust 7, 2008
K053444kowa co.KOWA KT-800June 9, 2006
K060780ryazan state instrumentsTONOMETER DIATONApril 6, 2006
K042099retinapharma technologiesTONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)December 10, 2004
K032799reichertNON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZERJanuary 20, 2004
K031733nidekNON-CONTACT TONOMETER, MODEL NT-4000December 4, 2003
K023676optilasa, s.lAPPLANATION TONOMETERApril 24, 2003