Cleared Traditional

Tono-Vera? Tonometer and Ocu-Dot? Tonometer Probes (16305, 16306, 16318)

K233516 · Reichert, Inc. · Ophthalmic

May 2024

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K233516 is an FDA 510(k) clearance for the Tono-Vera? Tonometer and Ocu-Dot? Tonometer Probes (16305, 16306, 16318), a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on May 1, 2024, 182 days after receiving the submission on November 1, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K233516 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 2023
Decision Date	May 01, 2024
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF