# K232567: Myriad SPECTRA Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Nico Corporation
- Decided: Mar 14, 2024 after 203 days
- Product code: QFX (Diagnostic Neurosurgical Microscope Filter)
- Device class: 2
- Regulation: 21 CFR 882.4950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180024 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180024: Leica FL400, Leica Microsystems (Schweiz) AG (2019) Summary page 5.

## Recalls of this device
- Oct 31, 2025 · Class II · Z-0600-2026: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.

## Indications for use
The Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore. The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

Source page: https://510kreport.com/device/K232567
Methodology: https://510kreport.com/methodology