Cleared Traditional

K123464 - CALLISTO EYE

K123464 is the FDA 510(k) clearance for CALLISTO EYE by Carl Zeiss Meditec, AG. It is a Class 2 Ophthalmic device (product code NFJ) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K123464 · Carl Zeiss Meditec, AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 Peers - NFJ System, Image Management, Ophthalmic

All 32
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K123464.
Retina Workplace
K150467 · Carl Zeiss Meditec, AG · May 2015
FORUM GLAUCOMA WORKPLACE
K141297 · Carl Zeiss Meditec, AG · Oct 2014
FORUM GLAUCOMA WORKPLACE
K130648 · Carl Zeiss Meditec, AG · Jul 2013
FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH
K122938 · Carl Zeiss Meditec, AG · Nov 2012
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
K013694 · Nidek, Inc. · Nov 2002