Cleared Special

CATS-L Tonometer? Prism

K234037 · Cats Tonometer, LLC · Ophthalmic
Feb 2024
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K234037 is an FDA 510(k) clearance for the CATS-L Tonometer? Prism, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Cats Tonometer, LLC (Tucson, US). The FDA issued a Cleared decision on February 9, 2024, 50 days after receiving the submission on December 21, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K234037 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2023
Decision Date February 09, 2024
Days to Decision 50 days
Submission Type Special
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