ONV — Electrical Impedance Spectrometer Class II
FDA product code ONV covers "Electrical Impedance Spectrometer", a Class II medical device regulated under 21 CFR 878.1820. Submissions are reviewed by the General, Plastic Surgery panel.
Classification Details
- Product Code
- ONV
- Device Class
- Class II
- Regulation Number
- 878.1820
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.