Icare ST500
The iCare ST500 measures intraocular pressure by rebound tonometry while the patient sits upright at a slit lamp. It is designed for healthcare professionals and is mounted with the ST500…
The iCare ST500 measures intraocular pressure by rebound tonometry while the patient sits upright at a slit lamp. It is designed for healthcare professionals and is mounted with the ST500 adapter rather than used as a handheld instrument.
A lightweight single-use probe briefly contacts the centre of the cornea and rebounds. Its magnetised shaft induces a signal in a surrounding coil, allowing the device to measure motion parameters such as deceleration and rebound time and calculate eye pressure.
Listed Item
iCare ST500 tonometer
Measurement and Power
The displayed reading is derived from six rebounds and stored for later retrieval. A rechargeable battery is charged in the SmartCradle, and controls on the instrument or a wireless remote operate the tonometer.
Who Else Makes It
Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Icare Finland Oy, Finland |
|---|---|
| FDA product code | HKY |
| Device type | Tonometer, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1930 |
| Establishment | Manufacturer |
| 510(k) | K241447 |
| Record published | 2025-12-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TA04 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tonometer AT 900 | Haag-Streit AG | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 7 |
| Ocu-Film® +” | Reichert Inc. | 5 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 5 |
| AccuTip Cover | Accutome, Inc. | 4 |
| Mediworks | Shanghai Mediworks Precision Instruments Co., Ltd. | 4 |
| Applanation Tonometer | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 3 |
| Icare ic200 | Icare Finland Oy | 3 |
| Marco | Takagi Seiko Co., Ltd. | 2 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 2 |
| iCare PATIENT2 | Icare Finland Oy | 2 |
| Tonometer AT 870 | Haag-Streit AG | 2 |
Showing 12 of 71. All products under Tonometer, Manual
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241447 | 2024-09-27 |
| K220852 | 2022-10-06 |
| K211355 | 2022-01-25 |
| K200966 | 2020-05-07 |
| K190316 | 2020-01-14 |
| K163343 | 2017-03-21 |
| K153694 | 2016-04-19 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.