Cleared Traditional

K122938 - FORUM FORUM ARCHIVE FORUM ARCHIVE & VIE...

K122938 is the FDA 510(k) clearance for FORUM FORUM ARCHIVE FORUM ARCHIVE & VIE... by Carl Zeiss Meditec, AG. It is a Class 2 Ophthalmic device (product code NFJ) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K122938 · Carl Zeiss Meditec, AG · Ophthalmic device
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Nov 2012
Decision
39d
Days
Class 2
Risk

K122938 is an FDA 510(k) clearance for the FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on November 2, 2012 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carl Zeiss Meditec, AG devices

Submission Details

510(k) Number K122938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2012
Decision Date November 02, 2012
Days to Decision 39 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 110d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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.

Regulatory Consultant

Regulatory Technology Services, LLC

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.