OYD · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.1820
Classification
FDA Product Code
OYD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.1820
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.