Tonometer, Ac-Powered
FDA product code HKX · Class II (moderate risk) · 21 CFR 886.1930 · Ophthalmic
58510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Keeler Instruments, Inc. 5
- Bio-Rad 5
- Reichert, Inc. 2
- Luneau SA 2
- Nidek, Inc. 2
- Ocular Blood Flow Laboratories, Inc. 2
- CooperVision, Inc. 2
- Optical Radiation Corp. 1
- Eyetech, LLC 1
- Ameritek, Inc. 1
- Woodlyn, Inc. 1
- Topcon Instrument Corporation of America 1
- Krb Ent. 1
- Richmond Products, Inc. 1
- Professional Technologies Corp. 1
- Sonometrics Systems, Inc. 1
- Topcon Corporation 1
- Reichert Ophthalmic Instruments, Div. Leica, Inc. 1
- Canon, Inc. 1
- American Optical Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253039 | Auto Kerato-Refracto Tonometer TRK-3 OmniaHKX · Traditional | Topcon Corporation | 11/07/2025SE |
| K223739 | VS Tabletop TonometerHKX · Traditional | Medimaging Integrated Solution, Inc. | 11/08/2023SE |
| K190382 | Intraocular Pressure Tonometer EASYTONHKX · Traditional | Company Elamed | 12/06/2019SE |
| K181260 | MiiS Horus Scope DPT 100HKX · Traditional | Medimaging Integrated Solution, Inc (Miis) | 06/21/2019SE |
| K181143 | Keeler TonoCare TonometerHKX · Traditional | Keeler Instruments, Inc. | 02/08/2019SE |
| K180820 | Tono Vue Non-Contact TonometerHKX · Traditional | Crystalvue Medical Corporation | 12/14/2018SE |
| K162067 | VX130 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 04/24/2017SE |
| K143086 | VX120 Ophthalmic Diagnostic DeviceHKX · Traditional | Luneau Sas | 06/01/2015SE |
| K113066 | Corvis STHKX · Traditional | Oculus Optikgerate GmbH | 11/08/2012SE |
| K111710 | Full Auto Tonometer Model TX-20HKX · Special | Canon Inc. -Medical Equipment Group | 09/20/2011SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | Keeler Instruments, Inc. | 12/10/2010SE |
| K083377 | AccupenHKX · Traditional | Accutome Ultrasound, Inc. | 07/27/2009SE |
| K073087 | Non-Contact Tonometer, Model FT-1000HKX · Traditional | Tomey Corporation | 11/18/2008SE |
| K081756 | Ocular Response AnalyzerHKX · Traditional | Reichert, Inc. | 08/07/2008SE |
| K053444 | Kowa KT-800HKX · Traditional | Kowa Co. , Ltd. | 06/09/2006SE |
| K060780 | Tonometer DiatonHKX · Traditional | Ryazan State Instruments | 04/06/2006SE |
| K042099 | Tonopach Ultrasonic Tonometer/Pachymeter Model P-201 (the Tonopach)HKX · Traditional | Retinapharma Technologies, Inc. | 12/10/2004SE |
| K032799 | Non-Contact Tonometers, Ocular Response AnalyzerHKX · Traditional | Reichert, Inc. | 01/20/2004SE |
| K031733 | Non-Contact Tonometer, Model NT-4000HKX · Traditional | Nidek, Inc. | 12/04/2003SE |
| K023676 | Applanation TonometerHKX · Traditional | Optilasa, S.L. | 04/24/2003SE |
| K023816 | Canon Full Auto Tonometer Tx-FHKX · Traditional | Canon, Inc.-Utsunomiya Optical Products Operation | 11/26/2002SE |
| K021937 | TGDC-01 PraHKX · Traditional | Truevision Instruments | 10/11/2002SE |
| K013805 | Kowa Automated Tonometer KT-500HKX · Traditional | Kowa Optimed, Inc. | 10/11/2002SE |
| K013259 | Portable Non-Contact Tonometer, Model PT100HKX · Traditional | Leica Microsystems, Inc. O.I.D. | 02/20/2002SE |
| K010998 | Langham Ocular Blood Flow (Obf) Tonograph/Tonometer Model 201HKX · Traditional | Langham Ophthalmic Technologies | 06/27/2001SESU |
| K002395 | Model 30 Classic PneumatonometerHKX · Traditional | Xomed, Inc. | 12/11/2000SE |
| K002510 | SmartlensHKX · Traditional | Odc Ophthalmic Development Co. AG | 10/18/2000SE |
| K990869 | Leica AT550HKX · Traditional | Leica Microsystems, Inc. | 06/07/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | Keeler Instruments, Inc. | 03/25/1999SE |
| K963079 | Canon TX-10 TonometerHKX · Traditional | Canon USA, Inc. | 03/03/1997SE |
| K953031 | Zeimer Self TonometerHKX · Traditional | Cds Technologies | 08/22/1995SE |
| K945972 | Digital Averaging TonometerHKX · Traditional | Opti-Med Electronics | 08/17/1995SE |
| K943939 | Non-Contact Tonometer T-2HKX · Traditional | Canon, Inc. | 05/12/1995SE |
| K941865 | Xpert NCTHKX · Traditional | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 09/29/1994SE |
| K921443 | Tip & Membrane AssemblyHKX · Traditional | Bio-Rad | 06/22/1993SE |
| K924777 | Burton Applanation Tonometer - Model T850 & T1000HKX · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K921617 | Cylinder of Gas, Can of Gas (CC12F2)HKX · Traditional | Bio-Rad | 08/05/1992SE |
| K913189 | Nidek Model NT-1000HKX · Traditional | Nidek, Inc. | 10/15/1991SE |
| K911721 | Keeler Pulsair Non Contact Tonometer, ModificationHKX · Traditional | Keeler Instruments, Inc. | 06/25/1991SE |
| K895575 | Bio-Rad Modular Air CompressorHKX · Traditional | Bio-Rad | 10/31/1989SE |
| K884012 | Mmac II TonometerHKX · Traditional | Professional Technologies Corp. | 01/06/1989SE |
| K873917 | Tonometer TapesHKX · Traditional | Richmond Products, Inc. | 11/02/1987SE |
| K873422 | Obf Model 115 Computer Tonometer SystemHKX · Traditional | Ocular Blood Flow Laboratories, Inc. | 11/02/1987SE |
| K871935 | T P C (Tonometer Probe Cover)HKX · Traditional | Krb Ent. | 06/03/1987SE |
| K871335 | Topcon Computerized Tonometer CT-10HKX · Traditional | Topcon Instrument Corporation of America | 05/18/1987SE |
| K870750 | Keeler Pulsair Non Contact TonometerHKX · Traditional | Keeler Instruments, Inc. | 03/17/1987SE |
| K870121 | Digilab Micro One Applanation TonometerHKX · Traditional | Bio-Rad | 02/20/1987SE |
| K864959 | Obf Model 112 Vacuum Cup SystemHKX · Traditional | Ocular Blood Flow Laboratories, Inc. | 02/12/1987SE |
| K863235 | Surgical Iop MonitorHKX · Traditional | Ameritek, Inc. | 09/25/1986SE |
| K863217 | Digilab Modular One-Applanation TonometerHKX · Traditional | Bio-Rad | 09/24/1986SE |
| K863200 | Computon(R)HKX · Traditional | Optical Radiation Corp. | 09/03/1986SE |
| K843354 | Episcleral Venous PressureHKX · Traditional | Eyetech, LLC | 11/19/1984SE |
| K841762 | Woodlyn Applanation TonometerHKX · Traditional | Woodlyn, Inc. | 08/02/1984SE |
| K840836 | Cat 100HKX · Traditional | CooperVision, Inc. | 06/19/1984SE |
| K833494 | Clerz Lubricating/Rewetting SolutionHKX · Traditional | CooperVision, Inc. | 01/04/1984SE |
| K820751 | GlaukonHKX · Traditional | Sonometrics Systems, Inc. | 04/09/1982SE |
| K802419 | Ao Non-Contact II TonometerHKX · Traditional | American Optical Corp. | 11/12/1980SE |
| K801518 | Span-Aid Bridging Pillow SystemHKX · Traditional | Span-America Medical Systems, Inc. | 08/04/1980SE |