OYD
- 产品代码
- OYD
- 器械名称
- Optical Diagnostic Device For Melanoma Detection
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 878.1820
- FDA 专业组
- General, Plastic Surgery
- 上市路径
- 需提交 510(k) 上市前通告
FDA 分类定义
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.