Device typeDermatological elastic scattering spectroscopy probe: An electrically-powered, hand-held device designed to use elastic scattering spectroscopy (ESS) to non-invasively evaluate a skin lesion clinically suspicious of carcinoma (e.g., melanoma, squamous cell, basal cell) to help guide subsequent clinical steps (e.g., referral, biopsy, excision). Scattered light processed from ESS is used to assess skin cellular and sub-cellular structure. It typically consists of a hand-held probe with controls/display and a tip placed on the skin surface to emit/receive light.
FDA categorySoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
Device ID00850017786004
MRI safetyMR Unsafe