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Nevisense Electrical Impedance Spectrometer

FDA PMA

Class II (US FDA PMA)

PMA P150046

by Scibase AB

Identity

Trade Name
NEVISENSE FDA PMA
Generic Name
Electrical Impedance Spectrometer FDA PMA

Identifiers

PMA Number
P150046 FDA PMA
FDA Product Code
ONV FDA PMA

Classification

Device Class
Class II FDA PMA
Legislation / Framework
21 CFR Part 878.1820 FDA PMA
Regulation Number
878.1820 FDA PMA
Advisory Committee
General, Plastic Surgery FDA PMA
FDA Decision
APRL FDA PMA

The Nevisense is an Electrical Impedance Spectrometer, a diagnostic device designed to assess cutaneous lesions. It provides additional information when evaluating suspicious skin lesions for potential melanoma, based on clinical or historical characteristics. The device operates by measuring electrical impedance within lesions to aid dermatologists in decision-making regarding biopsy.

Nevisense is supplied as a handheld probe system for use on primary skin lesions measuring between 2 mm and 20 mm in diameter. It is intended for intact, non-ulcerated, non-bleeding lesions without scars, fibrosis, foreign matter, or conditions like psoriasis, eczema, or sunburn. The device is not approved for use on hair-covered areas, acral skin, genitalia, mucosal surfaces, or eyes. Authorized under FDA PMA (P150046), it is classified as a Class II medical device under regulation 878.1820.

Frequently asked questions

What types of skin lesions can the Nevisense device evaluate, and what size range does it support?

The Nevisense is designed to evaluate primary skin lesions that are intact, non-ulcerated, and non-bleeding, with no scars, fibrosis, foreign matter, or conditions like psoriasis, eczema, or sunburn. It is specifically intended for lesions between 2 mm and 20 mm in diameter and must be accessible by the handheld probe. The device is not approved for use on hair-covered areas, acral skin, genitalia, mucosal surfaces, or eyes.

How is the Nevisense device used in clinical decision-making for melanoma assessment?

Nevisense provides additional information about suspicious cutaneous lesions by measuring electrical impedance within the lesion. It is meant to assist dermatologists in decision-making regarding biopsy when clinical or historical characteristics suggest potential melanoma. However, the device’s output is one element of the overall clinical assessment—it should be used alongside clinical and historical signs, not as a standalone diagnostic tool. It is not intended for lesions that are clinically obvious as melanoma.

Is the Nevisense probe single-use or reusable, and how should it be stored?

The Nevisense device is supplied as a handheld probe system, but the data does not specify whether the probe itself is single-use or reusable. Storage instructions are not detailed in the provided information. For proper use, ensure the probe is clean and suitable for the intended application, as it must be applied to accessible, intact lesions without interference from hair, scars, or other conditions.

What regulatory pathway was followed for Nevisense’s approval, and what classification does it hold?

Nevisense was approved under the FDA’s Premarket Approval (PMA) pathway, with the approval number P150046. It is classified as a Class II medical device under regulation 878.1820, indicating it has been determined to be of moderate risk and requires a higher level of regulatory oversight than Class I devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Scibase AB

Sources (1)

  • FDA PMA P150046 24 fields · synced Oct 6, 2026