Devices · SCIBASE AB

NEVISENSE

SCIBASE AB is listed for NEVISENSE (P150046). The FDA list gives June 28, 2017 as the date of the final decision. The lead panel is General and Plastic Surgery, and the database link on the FDA list is the PMA pathway. openFDA describes product code ONV as “Electrical Impedance Spectrometer”: An electrical impedance spectrometer is a prescription device that measures and analyzes electrical impedance properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and historical signs of skin cancer to obtain additional information prior to a decision to biopsy. It is not for use as a standalone diagnostic and is not for use to confirm a clinical diagnosis Please reference https://www.federalregister.gov/documents/2026/03/25/2026-05772/general-and-plastic-surgery-devices-reclassification-of-optical-diagnostic-devices-for-melanoma. openFDA records decision code APRL for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150046

Official FDA database record

Date of final decision

June 28, 2017

Company on the FDA list

SCIBASE AB

Lead panel

General and Plastic Surgery

Primary product code

ONV

openFDA device name for the code

Electrical Impedance Spectrometer

Device class

2

Regulation number

878.1820

openFDA decision description

Not returned

openFDA decision code

APRL

Statement or summary label

Statement