Optical Diagnostic Device For Melanoma Detection
The Optical Diagnostic Device for Melanoma Detection is an imaging device intended to detect melanoma and high-grade lesions among atypical skin lesions in order to rule out melanoma. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) given the critical importance of accurate melanoma detection. The product code is OYD, reviewed under the general and plastic surgery panel, with no regulation number assigned.
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Basic Information
- Product Code
- OYD
- Device Class
- FDA class 2
- Regulation Number
- 878.1820
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
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.