Data / Medical devices / United States / Lumicell, Inc
Lumicell, Inc: FDA-registered device maker in Waltham, MA, United States, 1 PMA approval
Lumicell, Inc is registered with the FDA (registration 3017718237) in Waltham, MA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated April 17, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017718237
- Address
- 307 Waverly Oaks Rd Ste 309, Waltham, MA, United States, 02452
- Owner or operator
- Lumicell, Inc (10090701)
- Roles
- Manufacturer
- First device listed
- April 30, 2024
- Registered through
- 2026
- Brand names listed
- Lumicell Direct Visualization System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fluorescence Imaging For Breast Cancer Detection | SAW | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 17, 2024 | P230014 | Lumicell Direct Visualization System (DVS) | SAW | 4 | November 25, 2025 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 31, 2025 | 97316 | Class II | Ongoing | Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Model/Catalog Number: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Software Vers | 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 and potentially leading to surgical site infections. | accessdata.fda.gov |
Compare with other makers
Updated November 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.