OYD · Optical Diagnostic Device For Melanoma Detection
General, Plastic Surgery · 21 CFR 878.1820 · Class 2
Overview
| Product Code | OYD |
|---|---|
| Device Name | Optical Diagnostic Device For Melanoma Detection |
| Regulation | 21 CFR 878.1820 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
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.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P090012 | MELAFIND | Strata Skin Sciences, Inc. | Nov 1, 2011 | APPR |
Top Applicants
- Strata Skin Sciences, Inc. — 1 clearance
