Cleared Traditional

iCare ST500 (TA04)

K241447 · Icare Finland OY · Ophthalmic
Sep 2024
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K241447 is an FDA 510(k) clearance for the iCare ST500 (TA04), a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Icare Finland OY (Vantaa, FI). The FDA issued a Cleared decision on September 27, 2024, 128 days after receiving the submission on May 22, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K241447 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2024
Decision Date September 27, 2024
Days to Decision 128 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