Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1930](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1930) → HKX — Tonometer, Ac-Powered # HKX · Tonometer, Ac-Powered _Ophthalmic · 21 CFR 886.1930 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX ## Overview - **Product Code:** HKX - **Device Name:** Tonometer, Ac-Powered - **Regulation:** [21 CFR 886.1930](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1930) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) ## Identification A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma. ## Classification Rationale Class II. ## Recent Cleared Devices (20 of 58) Showing 20 most recent of 58 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253039](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K253039.md) | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | Nov 7, 2025 | SESE | | [K223739](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K223739.md) | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | Nov 8, 2023 | SESE | | [K190382](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K190382.md) | Intraocular Pressure Tonometer EASYTON | Company Elamed | Dec 6, 2019 | SESE | | [K181260](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K181260.md) | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | Jun 21, 2019 | SESE | | [K181143](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K181143.md) | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | Feb 8, 2019 | SESE | | [K180820](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K180820.md) | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | Dec 14, 2018 | SESE | | [K162067](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K162067.md) | VX130 Ophthalmic Diagnostic Device | Luneau Sas | Apr 24, 2017 | SESE | | [K143086](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K143086.md) | VX120 Ophthalmic Diagnostic Device | Luneau Sas | Jun 1, 2015 | SESE | | [K113066](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K113066.md) | CORVIS ST | Oculus Optikgerate GmbH | Nov 8, 2012 | SESE | | [K111710](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K111710.md) | FULL AUTO TONOMETER MODEL TX-20 | Canon Inc. -Medical Equipment Group | Sep 20, 2011 | SESE | | [K093298](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K093298.md) | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | Keeler Instruments, Inc. | Dec 10, 2010 | SESE | | [K083377](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K083377.md) | ACCUPEN | Accutome Ultrasound, Inc. | Jul 27, 2009 | SESE | | [K073087](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K073087.md) | NON-CONTACT TONOMETER, MODEL FT-1000 | Tomey Corporation | Nov 18, 2008 | SESE | | [K081756](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K081756.md) | OCULAR RESPONSE ANALYZER | Reichert, Inc. | Aug 7, 2008 | SESE | | [K053444](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K053444.md) | KOWA KT-800 | Kowa Co. , Ltd. | Jun 9, 2006 | SESE | | [K060780](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K060780.md) | TONOMETER DIATON | Ryazan State Instruments | Apr 6, 2006 | SESE | | [K042099](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K042099.md) | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) | Retinapharma Technologies, Inc. | Dec 10, 2004 | SESE | | [K032799](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K032799.md) | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | Reichert, Inc. | Jan 20, 2004 | SESE | | [K031733](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K031733.md) | NON-CONTACT TONOMETER, MODEL NT-4000 | Nidek, Inc. | Dec 4, 2003 | SESE | | [K023676](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K023676.md) | APPLANATION TONOMETER | Optilasa, S.L. | Apr 24, 2003 | SESE | ## Top Applicants - Bio-Rad — 5 clearances - Keeler Instruments, Inc. — 5 clearances - CooperVision, Inc. — 2 clearances - Luneau Sas — 2 clearances - Nidek, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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