Medical Device Manufacturer · FI , Vantaa

Icare Finland OY - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2016

Recent clearances: iCare ST500 (TA04), iCare IC200, iCare HOME2

7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - Icare Finland OY Ophthalmic ✕

7 devices
1-7 of 7
Cleared CT Sep 27, 2024
iCare ST500 (TA04)
K241447 · HKY
Ophthalmic · 128d
Cleared Oct 06, 2022
iCare IC200
K220852 · HKY
Ophthalmic · 197d
Cleared Jan 25, 2022
iCare HOME2
K211355 · HKY
Ophthalmic · 267d
Cleared May 07, 2020
Icare HOME Tonometer
K200966 · HKY
Ophthalmic · 27d
Cleared Jan 14, 2020
Icare ic200
K190316 · HKY
Ophthalmic · 335d
Cleared Mar 21, 2017
Icare HOME tonometer
K163343 · HKY
Ophthalmic · 112d
Cleared Apr 19, 2016
Icare ic100
K153694 · HKY
Ophthalmic · 118d
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