# K181537: GLOW800

- Pathway: 510(k) (Traditional)
- Applicant: Leica Microsystems (Schweiz) AG
- Decided: Sep 7, 2018 after 88 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: 7 generations back to K944261 (1994). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141136: Leica FL800, Leica Biosystems Richmond (2014) Summary page 4.

## Indications for use
The GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).

Source page: https://510kreport.com/device/K181537
Methodology: https://510kreport.com/methodology