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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
Generic NameFluorescence imaging for breast cancer detection
ApplicantLumicell, Inc.
275 Washington St., Suite 200
Newton, MA 02458
PMA NumberP230014
Supplement NumberS002
Date Received09/17/2024
Decision Date11/26/2024
Product Code SAW 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order 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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