FDA 510(k) Applications for Medical Device Product Code "HKX"
(Tonometer, Ac-Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K083377 | ACCUTOME ULTRASOUND, INC. | ACCUPEN | 07/27/2009 |
| K963079 | CANON U.S.A., INC. | CANON TX-10 TONOMETER | 03/03/1997 |
| K111710 | CANON, INC.-MEDICAL EQUIPMENT GROUP | FULL AUTO TONOMETER MODEL TX-20 | 09/20/2011 |
| K023816 | CANON, INC.-UTSUNOMIYA OPTICAL PRODUCTS OPERATION | CANON FULL AUTO TONOMETER TX-F | 11/26/2002 |
| K190382 | Company Elamed | Intraocular Pressure Tonometer EASYTON | 12/06/2019 |
| K180820 | Crystalvue Medical Corporation | Tono Vue Non-Contact Tonometer | 12/14/2018 |
| K181143 | Keeler Instruments Inc. | Keeler TonoCare Tonometer | 02/08/2019 |
| K990257 | KEELER INSTRUMENTS, INC. | KEELER PULSAIR 3000 NON CONTACT TONOMETER | 03/25/1999 |
| K093298 | KEELER INSTRUMENTS, INC. | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | 12/10/2010 |
| K053444 | KOWA CO. LTD. | KOWA KT-800 | 06/09/2006 |
| K013805 | KOWA OPTIMED, INC. | KOWA AUTOMATED TONOMETER KT-500 | 10/11/2002 |
| K010998 | LANGHAM OPHTHALMIC TECHNOLOGIES | LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 | 06/27/2001 |
| K990869 | LEICA MICROSYSTEMS, INC. | LEICA AT550 | 06/07/1999 |
| K013259 | LEICA MICROSYSTEMS, INC. O.I.D. | PORTABLE NON-CONTACT TONOMETER, MODEL PT100 | 02/20/2002 |
| K143086 | LUNEAU SAS | VX120 Ophthalmic Diagnostic Device | 06/01/2015 |
| K162067 | LUNEAU SAS | VX130 Ophthalmic Diagnostic Device | 04/24/2017 |
| K223739 | Medimaging Integrated Solution Inc | VS Tabletop Tonometer | 11/08/2023 |
| K181260 | Medimaging Integrated Solution Inc. (MiiS) | MiiS Horus Scope DPT 100 | 06/21/2019 |
| K031733 | NIDEK, INC. | NON-CONTACT TONOMETER, MODEL NT-4000 | 12/04/2003 |
| K113066 | OCULUS OPTIKGERATE GMBH | CORVIS ST | 11/08/2012 |
| K002510 | ODC OPHTHALMIC DEVELOPMENT CO. AG | SMARTLENS | 10/18/2000 |
| K023676 | OPTILASA S.L. | APPLANATION TONOMETER | 04/24/2003 |
| K032799 | REICHERT INC. | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | 01/20/2004 |
| K081756 | REICHERT INC. | OCULAR RESPONSE ANALYZER | 08/07/2008 |
| K042099 | RETINAPHARMA TECHNOLOGIES INC. | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) | 12/10/2004 |
| K060780 | RYAZAN STATE INSTRUMENTS | TONOMETER DIATON | 04/06/2006 |
| K073087 | TOMEY CORPORATION | NON-CONTACT TONOMETER, MODEL FT-1000 | 11/18/2008 |
| K021937 | TRUEVISION INSTRUMENTS | TGDC-01 PRA | 10/11/2002 |
| K002395 | XOMED, INC. | MODEL 30 CLASSIC PNEUMATONOMETER | 12/11/2000 |
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