Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart B — Diagnostic Devices](/submissions/SU/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 878.1820](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/878.1820) → ONV — Electrical Impedance Spectrometer

# ONV · Electrical Impedance Spectrometer

_General, Plastic Surgery · 21 CFR 878.1820 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/ONV

## Overview

- **Product Code:** ONV
- **Device Name:** Electrical Impedance Spectrometer
- **Regulation:** [21 CFR 878.1820](/submissions/SU/subpart-b%E2%80%94diagnostic-devices/878.1820)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P150046](/device/P150046.md) | NEVISENSE | Scibase AB | Jun 28, 2017 | APPR |

## Top Applicants

- Scibase AB — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/ONV](https://fda.innolitics.com/productcode/ONV)

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