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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 NumberS004
Date Received11/10/2025
Decision Date11/25/2025
Product Code SAW 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
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 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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