Product code HKX
- Device name
- Tonometer, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1930
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | 2025-11-07 |
| K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | 2023-11-08 |
| K190382 | Intraocular Pressure Tonometer EASYTON | Company Elamed | 2019-12-06 |
| K181260 | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | 2019-06-21 |
| K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | 2019-02-08 |
| K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | 2018-12-14 |
| K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | 2017-04-24 |
| K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | 2015-06-01 |
| K113066 | CORVIS ST | Oculus Optikgerate GmbH | 2012-11-08 |
| K111710 | FULL AUTO TONOMETER MODEL TX-20 | Canon Inc. -Medical Equipment Group | 2011-09-20 |
| K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | Keeler Instruments, Inc. | 2010-12-10 |
| K083377 | ACCUPEN | Accutome Ultrasound, Inc. | 2009-07-27 |
| K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | Tomey Corporation | 2008-11-18 |
| K081756 | OCULAR RESPONSE ANALYZER | Reichert, Inc. | 2008-08-07 |
| K053444 | KOWA KT-800 | Kowa Co. , Ltd. | 2006-06-09 |
| K060780 | TONOMETER DIATON | Ryazan State Instruments | 2006-04-06 |
| K042099 | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) | Retinapharma Technologies, Inc. | 2004-12-10 |
| K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | Reichert, Inc. | 2004-01-20 |
| K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 | Nidek, Inc. | 2003-12-04 |
| K023676 | APPLANATION TONOMETER | Optilasa, S.L. | 2003-04-24 |
| K023816 | CANON FULL AUTO TONOMETER TX-F | Canon, Inc.-Utsunomiya Optical Products Operation | 2002-11-26 |
| K021937 | TGDC-01 PRA | Truevision Instruments | 2002-10-11 |
| K013805 | KOWA AUTOMATED TONOMETER KT-500 | Kowa Optimed, Inc. | 2002-10-11 |
| K013259 | PORTABLE NON-CONTACT TONOMETER, MODEL PT100 | Leica Microsystems, Inc. O.I.D. | 2002-02-20 |
| K010998 | LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201 | Langham Ophthalmic Technologies | 2001-06-27 |
| K002395 | MODEL 30 CLASSIC PNEUMATONOMETER | Xomed, Inc. | 2000-12-11 |
| K002510 | SMARTLENS | Odc Ophthalmic Development Co. AG | 2000-10-18 |
| K990869 | LEICA AT550 | Leica Microsystems, Inc. | 1999-06-07 |
| K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | Keeler Instruments, Inc. | 1999-03-25 |
| K963079 | CANON TX-10 TONOMETER | Canon USA, Inc. | 1997-03-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719872711230 | MiiS | MEDIMAGING INTEGRATED SOLUTION INC. | 2026-04-29 |
| 04719876420046 | TonoVue | CRYSTALVUE MEDICAL CORPORATION | 2026-04-15 |
| 06430033851920 | iCare ST500 | ICARE FINLAND OY | 2025-12-05 |
| 04571130283343 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | TOPCON CORPORATION | 2025-11-17 |
| 07350023774307 | Calcibon | Biomet Biologics, LLC | 2025-10-09 |
| 03664188000589 | ZEISS | LUNEAU TECHNOLOGY OPERATIONS | 2025-03-11 |
| 03664188000558 | ESSILOR | LUNEAU TECHNOLOGY OPERATIONS | 2025-01-02 |
| 03664188000565 | ESSILOR | LUNEAU TECHNOLOGY OPERATIONS | 2025-01-02 |
| 06430033851784 | ST500 SmartCradle | ICARE FINLAND OY | 2024-11-07 |
| 06430033851791 | ST500 Adapter | ICARE FINLAND OY | 2024-11-07 |
| 06430033851807 | ST500 Remote | ICARE FINLAND OY | 2024-11-07 |
| 06430033851883 | iCare ST500 | ICARE FINLAND OY | 2024-11-07 |
| 00851158007683 | Eli Ezer | U.S. OPHTHALMIC, L.L.C. | 2024-01-25 |
| 04547451026709 | INAMI | INAMI & CO., LTD. | 2023-07-27 |
| 04547451026686 | INAMI | INAMI & CO., LTD. | 2023-07-27 |
| 03615020000458 | WAVE ANALYZER MEDICA 800 | ESSILOR INTERNATIONAL | 2023-07-25 |
| 08800019600411 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | 2023-06-12 |
| 08800019600435 | Non-contact Tonometer HNT-1P | Huvitz Co., Ltd. | 2023-06-12 |
| 08800019600558 | Auto Tono/Refracto/Kerato/Pachymeter HTR-1A | Huvitz Co., Ltd. | 2023-06-12 |
| 03664188000923 | RODENSTOCK | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 03664188000404 | RODENSTOCK | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 03664188000145 | Visionix VX650 | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 03664188000930 | RODENSTOCK | LUNEAU TECHNOLOGY OPERATIONS | 2023-06-08 |
| 04047844051269 | DIPLOMAT Def. | SIGNUS Medizintechnik GmbH | 2022-06-20 |
| 04047844051276 | DIPLOMAT Def. | SIGNUS Medizintechnik GmbH | 2022-06-20 |
| 04582273600263 | NON-CONTACT TONOMETER | TOMEY CORPORATION. | 2022-04-01 |
| 00851158007706 | Eli Ezer | U.S. OPHTHALMIC, L.L.C. | 2021-01-04 |
| M6333974340 | JEDMED | JEDMED INSTRUMENT COMPANY | 2020-09-01 |
| 08437016886021 | OPTILASA | OPTILASA S.L. | 2017-04-26 |
| 08437016886014 | OPTILASA | OPTILASA S.L. | 2017-04-26 |