Icare Clinic

Icare CLINIC is software for storing and reviewing intraocular pressure measurements received from compatible Icare tonometers. It maintains a patient database and measurement history,…

Registry build 21.09.26

Icare CLINIC is software for storing and reviewing intraocular pressure measurements received from compatible Icare tonometers. It maintains a patient database and measurement history, allowing pressure readings from different visits or measurement sessions to be kept together.

The software shows and prints charts based on the stored measurements. Icare EXPORT transfers readings from the tonometer into the CLINIC database, providing a route from the measuring instrument to the patient’s record.

Data Exchange

CLINIC can export measurement data to external systems and import data from external systems. It serves as a software accessory to the tonometer, with measurement acquisition performed by the compatible instrument.

5manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (2), Beijing (1), Shanghai (1).

Chinese manufacturers registered for FDA product code HKY
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

Regulatory record for Icare Clinic
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) K190316
Record published 2020-02-05

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Icare Clinic
Catalogue number Size Status
TS02 In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer