Cleared Traditional

iCare IC200

K220852 · Icare Finland OY · Ophthalmic
Oct 2022
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K220852 is an FDA 510(k) clearance for the iCare IC200, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Icare Finland OY (Vantaa, FI). The FDA issued a Cleared decision on October 6, 2022, 197 days after receiving the submission on March 23, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K220852 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 2022
Decision Date October 06, 2022
Days to Decision 197 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