ONV · Electrical Impedance Spectrometer
General, Plastic Surgery · 21 CFR 878.1820 · Class 2
Overview
| Product Code | ONV |
|---|---|
| Device Name | Electrical Impedance Spectrometer |
| Regulation | 21 CFR 878.1820 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
It is indicated for use on cutaneous lesions with one or more clinical or historical characteristics of melanoma, when a dermatologist chooses to obtain additional information when considering biopsy. It should not be used on clinically obvious melanoma. It is to be used as one element of the overall clinical assessment. The output given by the device should be used in combination with clinical and historical signs of melanoma to obtain additional information prior to a decision to biopsy. 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 | NEVISENSE | Scibase AB | Jun 28, 2017 | APPR |
Top Applicants
- Scibase AB — 1 clearance
