Cleared Traditional

Icare ic200

K190316 · Icare Finland OY · Ophthalmic
Jan 2020
Decision
335d
Days
Class 2
Risk

About This 510(k) Submission

K190316 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 January 14, 2020, 335 days after receiving the submission on February 13, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K190316 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2019
Decision Date January 14, 2020
Days to Decision 335 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