1 device · 1 company · 2011
Product code OYD: Optical Diagnostic Device For Melanoma Detection
1 device under product code OYD, 2011, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (0 of 1 here), the regulation, and MAUDE report counts by product code.
Optical Diagnostic Device For Melanoma Detection. 21 CFR 878.1820, Class II. 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. MAUDE held 0 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| MELAFINDP090012 · PMA | STRATA SKIN SCIENCES, INC. | General and Plastic Surgery | database entry |
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