Cleared Traditional

CATS?-D Tonometer Prism

K203850 · Cats Tonometer, LLC · Ophthalmic

Jun 2021

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K203850 is an FDA 510(k) clearance for the CATS?-D 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 June 14, 2021, 165 days after receiving the submission on December 31, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number	K203850 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2020
Decision Date	June 14, 2021
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF