Cleared Special

Icare HOME Tonometer

K200966 · Icare Finland OY · Ophthalmic
May 2020
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K200966 is an FDA 510(k) clearance for the Icare HOME Tonometer, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Icare Finland OY (Vantaa, FI). The FDA issued a Cleared decision on May 7, 2020, 27 days after receiving the submission on April 10, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K200966 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2020
Decision Date May 07, 2020
Days to Decision 27 days
Submission Type Special
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