# K080612: Leica FL800

- Pathway: 510(k) (Traditional)
- Applicant: Leica Microsystems (Schweiz) AG
- Decided: May 9, 2008 after 66 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K944261 (1994). 8 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061871: Leica Model FL800, Leica Microsystems, Inc. (2006) Summary page 1.
- K071037: Spy Intra-Operative Imaging System, Model SP2000, Novadaq Technologies, Inc. (2007) Summary page 2.
- K072222: Spy Fluorescent Imaging System, Novadaq Technologies, Inc. (2007) Summary page 1.

## Most influential descendants
- K100468: Zeiss Infrared 800 with Flow 800 Option (2010), 4 descendants of its own
- K141136: Leica FL800 (2014), 3 descendants of its own
- K202391: DIR 800 (2021), 1 descendant of its own
- K243077: Affirm 800 (2025), 0 descendants of its own
- K231986: Modus IR (2024), 0 descendants of its own

## Indications for use
The Leica FL800 is a surgical microscope accessory used in viewing bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K080612
Methodology: https://510kreport.com/methodology