Optical Diagnostic Device For Melanoma Detection

Product Code: OYD

General Optical Products / Medical

Definition: Intended In The Detection Of Melanoma And High Grade Lesions Among Atypical Lesions In Order To Rule-out Melanoma.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as OYD

5960Optical Diagnostic Device For Melanoma Detection

Total Product Life Cycle (TPLC) Devices

5960Optical Diagnostic Device For Melanoma Detection

Pre-market Approvals for OYD

P090012MELAFINDSTRATA SKIN SCIENCES, INC.
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