Product code
OYD: Optical diagnostic device for melanoma detection
FDA product code · Class III · General & Plastic Surgery
Key facts
| Product code | OYD |
|---|---|
| Device | Optical diagnostic device for melanoma detection |
| Device class | Class III |
| Review panel | General & Plastic Surgery |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Intended in the detection of melanoma and high grade lesions among atypical lesions in order to rule-out melanoma. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 1–9 PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database