Cleared Traditional

CLARUS

K191194 · Carl Zeiss Meditec, Inc. · Ophthalmic
Jun 2019
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K191194 is an FDA 510(k) clearance for the CLARUS, a Camera, Ophthalmic, Slit-scanning (Class II — Special Controls, product code QER), submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on June 25, 2019, 53 days after receiving the submission on May 3, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K191194 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2019
Decision Date June 25, 2019
Days to Decision 53 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code QER — Camera, Ophthalmic, Slit-scanning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120
Definition An Ophthalmic Slit-scanning Camera Is An Ac-powered Device Intended To Take Photographs Of The Eye And The Surrounding Area.