Cleared Special

K232944 - CALLISTO eye

K232944 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 Special 510(k) pathway after a 92-day FDA review.

K232944 · Carl Zeiss Meditec, AG · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
92d
Days
Class 2
Risk

K232944 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 December 21, 2023 after a review of 92 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K232944

510(k) Number K232944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2023
Decision Date December 21, 2023
Days to Decision 92 days
Submission Type Special
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
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

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 52
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K232944.
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K232944 · CALLISTO eye
Download PDF FDA Summary Carl Zeiss Meditec, AG