DEVICE: Large Sapphire Optic (00841494100162)

A mains electricity (AC-powered) device assembly intended to be used by a healthcare professional to non-invasively evaluate a skin lesion clinically suspicious for carcinoma (e.g., melanoma, squamous cell) and precursors, before making a decision to biopsy, that operates based on inelastic (Raman) scattering of monochromatic light to measure molecular vibrations and identify pathology associated tissue molecules (e.g., proteins, lipids). It is an optical system applied to the skin surface typically consisting of a hardware unit (e.g., diode laser, fibreoptic system, Raman probe, spectrograph, image sensor chip, detector, computer), software, and a connected probe used to scan the lesion.