Cleared Traditional

K123464 - CALLISTO EYE

K123464 is an FDA 510(k) clearance for CALLISTO EYE, 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 116-day FDA review.

K123464 · Carl Zeiss Meditec, AG · Ophthalmic device
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Mar 2013
Decision
116d
Days
Class 2
Risk

K123464 is an FDA 510(k) clearance for the CALLISTO EYE. 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 March 5, 2013 after a review of 116 days - within the typical 510(k) review window.

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: 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, AG devices

FDA 510(k) Submission Details - K123464

510(k) Number K123464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2012
Decision Date March 05, 2013
Days to Decision 116 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
6d slower than avg
Panel avg: 110d · This submission: 116d
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 Peers - NFJ System, Image Management, Ophthalmic

All 42
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K123464.
SYNERGY ODM
K132667 · Topcon Medical Systems, Inc. · Oct 2013
FORUM GLAUCOMA WORKPLACE
K130648 · Carl Zeiss Meditec, AG · Jul 2013
EXCELSIOR
K130453 · Eyekor, LLC · Apr 2013
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
K122938 · Carl Zeiss Meditec, AG · Nov 2012
OPTOS ADVANCE
K113696 · Optos Plc. · May 2012
CARA
K110869 · Diagnos, Inc. · Jul 2011