Cleared Traditional

K231676 - CALLISTO eye (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231676 · Carl Zeiss Meditec, AG · Ophthalmic device
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Aug 2023
Decision
80d
Days
Class 2
Risk

K231676 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 (Jena, DE). The FDA issued a Cleared decision on August 28, 2023 after a review of 80 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 K231676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2023
Decision Date August 28, 2023
Days to Decision 80 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
30d faster than avg
Panel avg: 110d · This submission: 80d
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 Consultant

Carl Zeiss Meditec, Inc.
Aditya Rao

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.