Clearance Summary
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) received FDA 510(k) clearance under submission number K231075, sponsored by Carl Zeiss Meditec, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2023-06-20.
- Submission: K231075
- Applicant / Sponsor: Carl Zeiss Meditec, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1600
- Decision date: 2023-06-20
Classification & Regulation
This clearance is catalogued under FDA product code IZI and 21 CFR 892.1600, within the Radiology review panel as a Class II device.