Electrical Impedance Spectrometer
The Electrical Impedance Spectrometer (product code ONV) is a Class 3 surgical device reviewed by the General, Plastic Surgery (SU) panel, requiring Premarket Approval (PMA). It is indicated for use on cutaneous lesions with clinical or historical characteristics of melanoma to provide dermatologists with additional information when considering a biopsy, and should be used as one element of the overall clinical assessment alongside clinical and historical signs of melanoma. The device is not an implant or life-sustaining, and no regulation number has been assigned.
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Basic Information
- Product Code
- ONV
- Device Class
- FDA class 2
- Regulation Number
- 878.1820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
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.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.