Lumicell Direct Visualization System (DVS)
FDA premarket approval P230014/S004 · decided 2025-11-25
Approval details
- PMA number
- P230014
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Lumicell Direct Visualization System (DVS)
- Generic name
- Fluorescence imaging for breast cancer detection
- Applicant
- Lumicell, Inc.
- Date received
- 2025-11-10
- Decision date
- 2025-11-25
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- SAW
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for changes to the labeling including additional caution/warning/guidance statements and updated labeling to address corrective actions taken with respect to breaking or detachment of elastic bands from the device during use.
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