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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLumicell Direct Visualization System (DVS)
Generic NameFluorescence imaging for breast cancer detection
ApplicantLumicell, Inc.
275 Washington St., Suite 200
Newton, MA 02458
PMA NumberP230014
Supplement NumberS003
Date Received11/14/2024
Decision Date01/03/2025
Product Code SAW 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a labeling update to add vaporized hydrogen peroxide cycles to the validated sterilization methods for reprocessing the Handheld Probe and Sterilization Tray used as part of the Lumicell DVS.
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