Lumicell Direct Visualization System (DVS)
FDA premarket approval P230014/S001 · decided 2024-05-29
Approval details
- PMA number
- P230014
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Lumicell Direct Visualization System (DVS)
- Generic name
- Fluorescence imaging for breast cancer detection
- Applicant
- Lumicell, Inc.
- Date received
- 2024-04-29
- Decision date
- 2024-05-29
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- SAW
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Newton, MA
- Statement
- changes to the Lumicell Direct Visualization System (DVS), consisting of a supplier change for the mirrors and lenses of the device and the implementation of a manufacturing fixture at the finished device manufacturer to facilitate the gluing procedure for the device
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