Cleared Traditional

K231075 - Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)

K231075 is an FDA 510(k) clearance for Fluorescence Accessories (YELLOW 560 an..., manufactured by Carl Zeiss Meditec, Inc.. The device is a Class 2 General & Plastic Surgery device with product code IZI cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K231075 · Carl Zeiss Meditec, Inc. · General & Plastic Surgery device
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Jun 2023
Decision
67d
Days
Class 2
Risk

K231075 is an FDA 510(k) clearance for the Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option). Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on June 20, 2023 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1600 - the FDA general and plastic surgery 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, Inc. devices

FDA 510(k) Submission Details - K231075

510(k) Number K231075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2023
Decision Date June 20, 2023
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 General & Plastic Surgery devices follow this clearance model.

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