Cleared Traditional

K150467 - Retina Workplace

K150467 is an FDA 510(k) clearance for Retina Workplace, manufactured by Carl Zeiss Meditec, AG. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K150467 · Carl Zeiss Meditec, AG · Ophthalmic device
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May 2015
Decision
87d
Days
Class 2
Risk

K150467 is an FDA 510(k) clearance for the Retina Workplace. Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on May 21, 2015 after a review of 87 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

FDA 510(k) Submission Details - K150467

510(k) Number K150467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2015
Decision Date May 21, 2015
Days to Decision 87 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
23d faster than avg
Panel avg: 110d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFJ Device Classification - Class 2, Special Controls

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

Carl Zeiss Meditec, Inc.
CHRISTINE DUNBAR

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.

Regulatory Peers - NFJ System, Image Management, Ophthalmic

All 34
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K150467.
CALLISTO eye
K180858 · Carl Zeiss Meditec, AG · Jun 2018
Ophthalmic Software Platform RX
K173689 · Canon Inc. -Medical Equipment Group · Feb 2018
Retina Workplace
K170638 · Carl Zeiss Meditec, AG · Jun 2017
FORUM GLAUCOMA WORKPLACE
K141297 · Carl Zeiss Meditec, AG · Oct 2014
FORUM GLAUCOMA WORKPLACE
K130648 · Carl Zeiss Meditec, AG · Jul 2013
CALLISTO EYE
K123464 · Carl Zeiss Meditec, AG · Mar 2013