Icare HOME2
The iCare HOME2 TA023 tonometer measures intraocular pressure using rebound tonometry. It is a handheld, battery operated prescription device for adult patients to use as an adjunct to…
The iCare HOME2 TA023 tonometer measures intraocular pressure using rebound tonometry. It is a handheld, battery operated prescription device for adult patients to use as an adjunct to routine clinical eye pressure monitoring.
A small, sterile, single use probe briefly touches the eye. The device calculates pressure from probe deceleration and rebound time, without topical anesthesia. Measurements can be taken with the patient upright or lying down.
Measurement Records
Results can be transferred to a computer or mobile device and uploaded through iCare EXPORT or iCare PATIENT2 for further review. Depending on the mobile system, transfer uses Bluetooth or a USB connection. The app displays measurements and supports their transfer to the clinical data service.
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) | K211355 |
| Record published | 2022-02-08 |
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 |
|---|---|---|
| TA023 | 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.