Cleared Traditional

Icare HOME tonometer

K163343 · Icare Finland OY · Ophthalmic

Mar 2017

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K163343 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 March 21, 2017, 112 days after receiving the submission on November 29, 2016. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K163343 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 29, 2016
Decision Date	March 21, 2017
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF