PMA P150046

Device: Nevisense
Applicant: Scibase AB
PMA number: P150046
Supplement: S004
Product code: ONV
Decision date: 2026-02-26
Generic name: Electrical Impedance Spectrometer
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.”

Current openFDA PMA Record#

Device: Nevisense
Applicant: Scibase AB
PMA number: P150046
Supplement: S005
Product code: ONV
Generic name: Electrical Impedance Spectrometer
Decision date: 2026-02-26
Decision code: APPR
Date received: 2025-12-02
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.”