Cleared Traditional

K243878 - CLARUS (700)

K243878 is an FDA 510(k) clearance for CLARUS (700), manufactured by Carl Zeiss Meditec, Inc.. The device is a Class 2 Ophthalmic device with product code QER cleared through the Traditional 510(k) pathway after a 120-day FDA review.

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

K243878 is an FDA 510(k) clearance for the CLARUS (700). Classified as Camera, Ophthalmic, Slit-scanning (product code QER), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on April 17, 2025 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Carl Zeiss Meditec, Inc. devices

FDA 510(k) Submission Details - K243878

510(k) Number K243878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QER Device Classification - Class 2, Special Controls

Product Code QER Camera, Ophthalmic, Slit-scanning
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.