PMA
P230014: Lumicell Direct Visualization System (DVS)
FDA PMA · Fluorescence imaging for breast cancer detection · Lumicell, Inc.
Key facts
| PMA number | P230014 |
|---|---|
| Trade name | Lumicell Direct Visualization System (DVS) |
| Generic name | Fluorescence imaging for breast cancer detection |
| Applicant | Lumicell, Inc. |
| Owner/operator | Lumicell, Inc |
| Product code | SAW |
| Approval date | Apr 17, 2024 |
| Establishment registration | 3017718237 |
| FEI number | 3017718237 |
At a glance
- 1–9 Supplements
- Nov 25, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: