Cleared Traditional

iCare HOME2

K211355 · Icare Finland OY · Ophthalmic
Jan 2022
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K211355 is an FDA 510(k) clearance for the iCare HOME2, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Icare Finland OY (Vantaa, FI). The FDA issued a Cleared decision on January 25, 2022, 267 days after receiving the submission on May 3, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K211355 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2021
Decision Date January 25, 2022
Days to Decision 267 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HKY — Tonometer, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930