# P230014: Lumicell Direct Visualization System (DVS)

- Pathway: PMA
- Applicant: Lumicell, Inc.
- Decided: Apr 17, 2024 after 369 days
- Product code: SAW (Fluorescence Imaging For Breast Cancer Detection)
- Device class: 3
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

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

## Recalls of this device
- Jul 31, 2025 · Class II · Z-2519-2025: The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity

Source page: https://510kreport.com/device/P230014
Methodology: https://510kreport.com/methodology