Cleared Traditional

CLARUS (700)

K243878 · Carl Zeiss Meditec, Inc. · Ophthalmic
Apr 2025
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K243878 is an FDA 510(k) clearance for the CLARUS (700), a Camera, Ophthalmic, Slit-scanning (Class II — Special Controls, product code QER), submitted by Carl Zeiss Meditec, Inc. (Dublic, US). The FDA issued a Cleared decision on April 17, 2025, 120 days after receiving the submission on December 18, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K243878 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2024
Decision Date April 17, 2025
Days to Decision 120 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.