Cleared Traditional

VS Tabletop Tonometer

K223739 · Medimaging Integrated Solution, Inc. · Ophthalmic

Nov 2023

Decision

329d

Days

Class 2

Risk

About This 510(k) Submission

K223739 is an FDA 510(k) clearance for the VS Tabletop Tonometer, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Medimaging Integrated Solution, Inc. (Hsinchu, CN). The FDA issued a Cleared decision on November 8, 2023, 329 days after receiving the submission on December 14, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K223739 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2022
Decision Date	November 08, 2023
Days to Decision	329 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF