iCare ST500 (TA04)
Icare Finland OY
Icare Finland Oy
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005324856 | 3005324856 | Icare Finland Oy | 1 | N | 2026-01-01 | Ayritie 22 Vantaa Uusimaa FI 01510 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 70989 | 1017686192 | K241447 | iCare ST500 (TA04) | HKY | 2024-09-27 |
| 70989 | 1624985229 | K220852 | iCare IC200 | HKY | 2022-10-06 |
| 70989 | 1178235149 | K211355 | iCare HOME2 | HKY | 2022-01-25 |
| 70989 | 1496746114 | K200966 | Icare HOME Tonometer | HKY | 2020-05-07 |
| 70989 | 1684482359 | K190316 | Icare ic200 | HKY | 2020-01-14 |
| 70989 | 1698717057 | K163343 | Icare HOME tonometer | HKY | 2017-03-21 |
| 70989 | 1517644187 | K153694 | Icare ic100 | HKY | 2016-04-19 |
| 70989 | 1664817212 | K063873 | ICARE TONOMETER TA01I | HKY | 2007-05-23 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HKY | 8 | 2024-09-27 |
PMN#
ICare IC200
Icare Finland Oy
iCare HOME2
Icare Finland OY
Icare HOME Tonometer
Icare Finland Oy
Icare Ic200
Icare Finland Oy
Icare HOME Tonometer
Icare Finland Oy
Icare Ic100
Icare Finland Oy
GUDID#
iCare ST500 - iCare ST500 tonometer
2025-12-05
iCare IC100 - The iCare IC100 tonometer is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidlyand without an anesthetic. The iCare IC100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
2025-12-04
iCare IC200 - iCare IC200 (with Quick Measure feature)
2025-12-04
Probes for HOME - Sales package 50pcs
2017-03-24
ST500 SmartCradle - TX02
2024-11-07
ST500 Adapter - TD01
2024-11-07
ST500 Remote - TR01
2024-11-07
iCare ST500 - iCare ST500 tonometer
2024-11-07
Icare HOME tonometer - TA022
2020-05-11
Icare TA01i - The Icare tonometer is used in the diagnosis, follow up and screening of glaucoma. It is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidly and without an anesthetic.The Icare tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
2016-09-23
iCare PATIENT2 - iCare PATIENT2 (iOS version)
2024-04-23
iCare PATIENT2 - iCare PATIENT2 (Android version)
2024-04-23
Icare PATIENT - TS04
2020-05-11
Icare ic200 - The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the need for topical anesthesia. The Icare ic200 tonometer measures the IOP by utilizing the rebound method. The Icare ic200 tonometer is intended to be used for the measurement of intraocular pressure of the human eye. Icare ic200 allows IOP measurement of patients in all positions between sitting and supine positions. IOP measurement result can be transferred to printer or to a PC via Bluetooth connection.
2020-01-17
Icare HOME tonometer - TA022
2017-03-24
iCare IC200 - iCare IC200 (with Quick Measure feature)
2023-06-20
Probes for HOME - Sales package 20pcs of TP022 probes
2020-04-15
Icare tonometer probes - TP01s
2016-12-01
Probes for HOME - Single unit blister package
2017-03-24
iCare HOME2 - TA023
2022-02-08
Icare CLINIC - TS02
2020-02-05
Icare EXPORT - TS03
2020-02-05
Icare ic100 - The Icare ic100 tonometer is based on induction-based rebound method, which allows intraocular pressure (IOP) to be measured accurately, rapidlyand without an anesthetic. The Icare ic100 tonometer is intended to be used for the measurement of intraocular pressure of the human eye.
2016-09-23