Cleared Traditional

K231075 - Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K231075 · Carl Zeiss Meditec, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
47d faster than avg
Panel avg: 114d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - IZI System, X-ray, Angiographic

All 196
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K231075.
IC-Flow™ Imaging System 2.0
K243645 · Diagnostic Green GmbH · Sep 2025
Affirm 800
K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jun 2025
Modus IR
K231986 · Synaptive Medical, Inc. · Mar 2024
EXPLORER AIR® II (8001, 8002, 8003)
K234090 · Surgvision GmbH · Mar 2024
DIR 800
K202391 · Aesculap, Inc. · Jan 2021