Lumicell Direct Visualization System
FDA premarket approval P230014/S002 · decided 2024-11-26
Approval details
- PMA number
- P230014
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lumicell Direct Visualization System
- Generic name
- Fluorescence imaging for breast cancer detection
- Applicant
- Lumicell, Inc.
- Date received
- 2024-09-17
- Decision date
- 2024-11-26
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- SAW
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Newton, MA
- Statement
- Approval for the addition of a trim-potentiometer to the electrical circuit of the light source and addition of a component-level power specification.
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