iCare HOME2— 510(k) K211355

Substantially Equivalent

Icare Finland OY

FDA 510(k) clearance K211355 for iCare HOME2, Substantially Equivalent on 2022-01-25. Applicant: Icare Finland OY. Device class: 2.

Clearance details

Applicant: Icare Finland OY
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2021-05-03
Decision date: 2022-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vantaa, FI

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKY

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K233516 — Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)2024-05-01
K234037 — CATS-L Tonometer Prism2024-02-09
K232143 — Applanation Tonometer HT-50002023-10-23
K220852 — iCare IC2002022-10-06

More clearances from Icare Finland OY

K200966 — Icare HOME Tonometer2020-05-07
K190316 — Icare ic2002020-01-14
K163343 — Icare HOME tonometer2017-03-21
K153694 — Icare ic1002016-04-19

Data sourced from openFDA. This site is unofficial and independent of the FDA.