Icare Home Tonometer
Icare Home is a handheld rebound tonometer for adult intraocular-pressure monitoring at home under professional supervision. A sterile, disposable probe briefly contacts the cornea without…
Icare Home is a handheld rebound tonometer for adult intraocular-pressure monitoring at home under professional supervision. A sterile, disposable probe briefly contacts the cornea without topical anesthesia.
The device measures probe deceleration and rebound time to calculate pressure. A complete sequence uses six readings and stores the final value, date, time, eye identification and measurement quality.
Data Transfer
Results can be transferred to Icare Clinic through desktop Icare Export or mobile Icare Patient software. The prescription device supplements routine clinical pressure monitoring and is powered by batteries.
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) | K200966 |
| Record published | 2020-05-11 |
| Record revised | 2024-05-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-05-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TA022 | Withdrawn |
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.