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/productcode/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](/device/K253039.md) | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | Nov 7, 2025 | SESE |
| [K223739](/device/K223739.md) | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | Nov 8, 2023 | SESE |
| [K190382](/device/K190382.md) | Intraocular Pressure Tonometer EASYTON | Company Elamed | Dec 6, 2019 | SESE |
| [K181260](/device/K181260.md) | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | Jun 21, 2019 | SESE |
| [K181143](/device/K181143.md) | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | Feb 8, 2019 | SESE |
| [K180820](/device/K180820.md) | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | Dec 14, 2018 | SESE |
| [K162067](/device/K162067.md) | VX130 Ophthalmic Diagnostic Device | Luneau Sas | Apr 24, 2017 | SESE |
| [K143086](/device/K143086.md) | VX120 Ophthalmic Diagnostic Device | Luneau Sas | Jun 1, 2015 | SESE |
| [K113066](/device/K113066.md) | CORVIS ST | Oculus Optikgerate GmbH | Nov 8, 2012 | SESE |
| [K111710](/device/K111710.md) | FULL AUTO TONOMETER MODEL TX-20 | Canon Inc. -Medical Equipment Group | Sep 20, 2011 | SESE |
| [K093298](/device/K093298.md) | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | Keeler Instruments, Inc. | Dec 10, 2010 | SESE |
| [K083377](/device/K083377.md) | ACCUPEN | Accutome Ultrasound, Inc. | Jul 27, 2009 | SESE |
| [K073087](/device/K073087.md) | NON-CONTACT TONOMETER, MODEL FT-1000 | Tomey Corporation | Nov 18, 2008 | SESE |
| [K081756](/device/K081756.md) | OCULAR RESPONSE ANALYZER | Reichert, Inc. | Aug 7, 2008 | SESE |
| [K053444](/device/K053444.md) | KOWA KT-800 | Kowa Co. , Ltd. | Jun 9, 2006 | SESE |
| [K060780](/device/K060780.md) | TONOMETER DIATON | Ryazan State Instruments | Apr 6, 2006 | SESE |
| [K042099](/device/K042099.md) | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) | Retinapharma Technologies, Inc. | Dec 10, 2004 | SESE |
| [K032799](/device/K032799.md) | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | Reichert, Inc. | Jan 20, 2004 | SESE |
| [K031733](/device/K031733.md) | NON-CONTACT TONOMETER, MODEL NT-4000 | Nidek, Inc. | Dec 4, 2003 | SESE |
| [K023676](/device/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

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**Source:** [https://fda.innolitics.com/productcode/HKX](https://fda.innolitics.com/productcode/HKX)

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