HKY · Tonometer, Manual
Ophthalmic · 21 CFR 886.1930 · Class 2
Overview
| Product Code | HKY |
|---|---|
| Device Name | Tonometer, Manual |
| Regulation | 21 CFR 886.1930 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241447 | iCare ST500 (TA04) | Icare Finland OY | Sep 27, 2024 | SESE |
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) | Reichert, Inc. | May 1, 2024 | SESE |
| K234037 | CATS-L Tonometer Prism | Cats Tonometer, LLC | Feb 9, 2024 | SESE |
| K232143 | Applanation Tonometer HT-5000 | Huvitz Co., Ltd. | Oct 23, 2023 | SESE |
| K220852 | iCare IC200 | Icare Finland OY | Oct 6, 2022 | SESE |
| K211355 | iCare HOME2 | Icare Finland OY | Jan 25, 2022 | SESE |
| K203850 | CATS®-D Tonometer Prism | Cats Tonometer, LLC | Jun 14, 2021 | SESE |
| K200966 | Icare HOME Tonometer | Icare Finland OY | May 7, 2020 | SESE |
| K190316 | Icare ic200 | Icare Finland OY | Jan 14, 2020 | SESE |
| K191314 | Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q | Chongqing Sunkingdom Medical Instrument Co., Ltd. | Dec 19, 2019 | SESE |
| K182491 | Applanation tonometer AT-2 | Takagi Seiko Co., Ltd. | Dec 10, 2018 | SESE |
| K180839 | AT 030 | Carl Zeiss Meditec, AG | Jun 7, 2018 | SESE |
| K173904 | CATS Tonometer Prism | Cats Tonometer, LLC | Mar 9, 2018 | SESE |
| K172728 | Applanation tonometer AT-1 | Takagi Seiko Co., Ltd. | Oct 17, 2017 | SESE |
| K163343 | Icare HOME tonometer | Icare Finland OY | Mar 21, 2017 | SESE |
| K153694 | Icare ic100 | Icare Finland OY | Apr 19, 2016 | SESE |
| K142263 | Applanation Tonometer | Shanghai Mediworks Precision Instruments Co. , Ltd. | Apr 15, 2016 | SESE |
| K151491 | Falck Medical Multifunction Tonometer, FAT1 | Falck Medical, Inc. | Jan 15, 2016 | SESE |
| K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | Keeler Limited | Dec 31, 2015 | SESE |
| K152308 | Sensor Medical Single Use Tonometer Prism | Sensor Medical Technology, LLC | Oct 13, 2015 | SESE |
Top Applicants
- Icare Finland OY — 7 clearances
- Cats Tonometer, LLC — 3 clearances
- Falck Medical, Inc. — 2 clearances
- Keeler Limited — 2 clearances
- Keeler, Ltd. — 2 clearances
