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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.
 
DeviceNevisense
Generic NameElectrical Impedance Spectrometer
Regulation Number878.1820
ApplicantScibase AB
Kammakargatan 22
Stockholm SE-1140
PMA NumberP150046
Supplement NumberS005
Date Received12/02/2025
Decision Date02/26/2026
Reclassified Date04/24/2026
Product Code ONV 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for replacing the user manual text, “Nevisense may only be used by dermatologists who have successfully completed the Nevisense training”, with the following:• “Only dermatologists, who have completed Nevisense training, may initiate a Nevisense examination and utilize the Nevisense results in conjunction with other clinical parameters toobtain additional information prior to decision to biopsy.”• “Nevisense may only be operated by healthcare professionals who have successfully completed the Nevisense training.”
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