FDA product code ONV: Electrical Impedance Spectrometer
ONV is the FDA product code for electrical impedance spectrometer. It is a Class II device, regulated under 21 CFR 878.1820 and reviewed by the General and Plastic Surgery panel. Devices under ONV reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Electrical Impedance Spectrometer |
| Device class | Class II |
| Regulation | 21 CFR 878.1820 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
Recalls for ONV devices
openFDA lists no recalls for product code ONV.
Frequently asked questions
What is FDA product code ONV?
ONV is the FDA product code for electrical impedance spectrometer. It is a Class II device, regulated under 21 CFR 878.1820 and reviewed by the General and Plastic Surgery panel.
What device class is ONV?
Class II, regulation 21 CFR 878.1820. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code ONV
- Run a recall and safety report across every ONV manufacturer
- Watch product code ONV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times