FDA product code OYD: Optical Diagnostic Device For Melanoma Detection
OYD is the FDA product code for optical diagnostic device for melanoma detection. It is a Class II device, regulated under 21 CFR 878.1820 and reviewed by the General and Plastic Surgery panel. Devices under OYD reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 1 recall for OYD devices.
Definition
An optical diagnostic device for melanoma detection is a prescription device that measures and analyzes optical 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 | Optical Diagnostic Device For Melanoma Detection |
| 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 OYD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-04-02.
Frequently asked questions
What is FDA product code OYD?
OYD is the FDA product code for optical diagnostic device for melanoma detection. 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 OYD?
Class II, regulation 21 CFR 878.1820. Typical premarket route: 510(k).
Have OYD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-04-02.
Next steps
- Run an FDA pathway report with predicate devices for product code OYD
- Run a recall and safety report across every OYD manufacturer
- Watch product code OYD 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.
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