Lumicell, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Lumicell, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SAW | Fluorescence Imaging For Breast Cancer Detection | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P230014 | PMA | Lumicell Direct Visualization System (DVS) | 2024-04-17 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-07-31.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Lumicell, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03686215: Investigation of Novel Surgical Imaging for Tumor Excision (Completed, started 2019-11-04)
- NCT03834272: Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies (Completed, started 2019-03-18)
- NCT03321929: Intraoperative Detection of Residual Cancer in Breast Cancer (Completed, started 2018-02-06)
- NCT02584244: Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers (Recruiting, started 2016-08-04)
- NCT02438358: Feasibility Study of Intraoperative Imaging in Breast Cancer (Completed, started 2015-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lumicell, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Lumicell, Inc.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Lumicell, Inc.?
The most frequent FDA product codes under this applicant name are SAW (Fluorescence Imaging For Breast Cancer Detection, 1).
Next steps
- See all 0 Lumicell, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SAW, Lumicell, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.