Cleared Traditional

K180858 - CALLISTO eye (FDA 510(k) Clearance)

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

K180858 · Carl Zeiss Meditec, AG · Ophthalmic device
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Jun 2018
Decision
86d
Days
Class 2
Risk

K180858 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 June 27, 2018 after a review of 86 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 K180858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2018
Decision Date June 27, 2018
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
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 50
Devices cleared under the same product code (NFJ) and FDA review panel - the closest regulatory comparables to K180858.
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