HKX · Tonometer, Ac-Powered
Ophthalmic · 21 CFR 886.1930 · Class 2
Overview
| Product Code | HKX |
|---|---|
| Device Name | Tonometer, Ac-Powered |
| Regulation | 21 CFR 886.1930 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
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 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | Topcon Corporation | Nov 7, 2025 | SESE |
| K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | Nov 8, 2023 | SESE |
| K190382 | Intraocular Pressure Tonometer EASYTON | Company Elamed | Dec 6, 2019 | SESE |
| K181260 | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | Jun 21, 2019 | SESE |
| K181143 | Keeler TonoCare Tonometer | Keeler Instruments, Inc. | Feb 8, 2019 | SESE |
| K180820 | Tono Vue Non-Contact Tonometer | Crystalvue Medical Corporation | Dec 14, 2018 | SESE |
| K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | Apr 24, 2017 | SESE |
| K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | Jun 1, 2015 | SESE |
| K113066 | CORVIS ST | Oculus Optikgerate GmbH | Nov 8, 2012 | SESE |
| K111710 | FULL AUTO TONOMETER MODEL TX-20 | Canon Inc. -Medical Equipment Group | Sep 20, 2011 | SESE |
| K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | Keeler Instruments, Inc. | Dec 10, 2010 | SESE |
| K083377 | ACCUPEN | Accutome Ultrasound, Inc. | Jul 27, 2009 | SESE |
| K073087 | NON-CONTACT TONOMETER, MODEL FT-1000 | Tomey Corporation | Nov 18, 2008 | SESE |
| K081756 | OCULAR RESPONSE ANALYZER | Reichert, Inc. | Aug 7, 2008 | SESE |
| K053444 | KOWA KT-800 | Kowa Co. , Ltd. | Jun 9, 2006 | SESE |
| K060780 | TONOMETER DIATON | Ryazan State Instruments | Apr 6, 2006 | SESE |
| K042099 | TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) | Retinapharma Technologies, Inc. | Dec 10, 2004 | SESE |
| K032799 | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER | Reichert, Inc. | Jan 20, 2004 | SESE |
| K031733 | NON-CONTACT TONOMETER, MODEL NT-4000 | Nidek, Inc. | Dec 4, 2003 | SESE |
| K023676 | 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
