# DEN180024: Leica FL400

- Pathway: De Novo (Direct)
- Applicant: Leica Microsystems (Schweiz) AG
- Decided: Mar 28, 2019 after 335 days
- Product code: QFX (Diagnostic Neurosurgical Microscope Filter)
- Device class: 2
- Regulation: 21 CFR 882.4950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K211346: BLUE 400 (2022), 2 descendants of its own
- K251286: Affirm 400 (2026), 0 descendants of its own
- K240215: Blue 400; Blue 400 S (2024), 0 descendants of its own
- K232567: Myriad SPECTRA Light Source (2024), 0 descendants of its own

## Indications for use
The Leica FL400 is a surgical microscope accessory filter set for viewing fluorescence of fluorophores comprising an excitation filter for blue spectral range 380 nm – 430 nm and an observation filter comprising the long-wave blue, green, yellow and red spectrum in the spectral band greater than 444 nm. The FL400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

Source page: https://510kreport.com/device/DEN180024
Methodology: https://510kreport.com/methodology