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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLumicell Direct Visualization System (DVS)
Generic NameFluorescence imaging for breast cancer detection
ApplicantLumicell, Inc.
275 Washington Street
Suite 200
Newton, MA 02458
PMA NumberP230014
Date Received04/14/2023
Decision Date04/17/2024
Product Code SAW 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT02438358
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR the Lumicell Direct Visualization System. This device is a fluorescence imaging system intended for use in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery. The Lumicell Direct Visualization System is used with optical imaging agent LUMISIGHT (pegulicianine) for injection for fluorescence imaging of the lumpectomy cavity.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 
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