Lumicell Direct Visualization System (DVS)
FDA premarket approval P230014 · decided 2024-04-17
Approval details
- PMA number
- P230014
- Trade name
- Lumicell Direct Visualization System (DVS)
- Generic name
- Fluorescence imaging for breast cancer detection
- Applicant
- Lumicell, Inc.
- Date received
- 2023-04-14
- Decision date
- 2024-04-17
- Days to decision
- 369 days
- Decision code
- APPR
- Product code
- SAW
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Newton, MA
- Statement
- APPROVAL FOR the Lumicell Direct Visualization System. This device is a fluorescence imaging system intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The Lumicell Direct Visualization System is used with optical imaging agent LUMISIGHT (pegulicianine) for injection for fluorescence imaging of the lumpectomy cavity.
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