Lumicell, Inc.
Country not established
- Devices
- 7
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Lumicell, Inc. makes
Lumicell, Inc. manufactures intraoperative tumour margin fluorescence imaging systems, including handheld probes, calibrators, and reusable sterilization containers designed for surgical use. The company also produces probe covers and spacers to complement its imaging technology, which aids in real-time visualisation of tissue margins during procedures. The systems are intended for use in identifying tumour boundaries during surgery to improve precision and reduce residual cancerous tissue.
The company’s devices are classified as Class III under FDA regulations, requiring Premarket Approval (PMA) or De Novo authorisation. These products are listed in the FDA’s Unique Device Identification (UDI) database, ensuring traceability and compliance with US regulatory requirements. The manufacturer is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
Lumicell Direct Visualization System (DVS) Ref P230014
Regimes: PMA Registry: PMA
Company details
- DUNS number
- 832329788
- [email protected]
- Phone
- 1-833-458-6387
FDA recalls
FDA recall records list 1 recall initiated by Lumicell, Inc., initiated on 2025-07-31. By recorded status: 1 ongoing. The reasons filed fall into these groups: sterility or contamination and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 31 Jul 2025 Z-2519-2025 Class II Ongoing 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.
Frequently asked questions
How many devices does Lumicell, Inc. have in the registry?
The registry currently lists 7 devices for Lumicell, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lumicell, Inc.'s devices?
Among its 7 most recently registered devices, Lumicell, Inc. has devices listed in FDA PMA (1 device) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Lumicell, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Lumicell, Inc.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Lumicell, Inc.?
FDA recall records list 1 recall initiated by Lumicell, Inc., the most recent initiated on 31 Jul 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Lumicell, Inc. in the registry?
The most recently registered devices listed for Lumicell, Inc. include Lumicell Direct Visualization System (DVS) 900-00209, Lumicell Direct Visualization System (DVS) 810-00212, Lumicell Direct Visualization System (DVS) 810-00211 and Lumicell Direct Visualization System (DVS) 810-00217.