Cleared Traditional

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

K231075 · Carl Zeiss Meditec, Inc. · General & Plastic Surgery

Jun 2023

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K231075 is an FDA 510(k) clearance for the Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option), a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Carl Zeiss Meditec, Inc. (Dublic, US). The FDA issued a Cleared decision on June 20, 2023, 67 days after receiving the submission on April 14, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number	K231075 FDA.gov
FDA Decision	Cleared 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