Important Safety Information
MelaFind® is intended to be used when a dermatologist chooses to obtain additional information for a decision to biopsy, but MelaFind® should NOT be used to confirm a clinical diagnosis of melanoma. As with all tools to provide additional Information during skin exams, there is a risk that melanomas will be missed and benign moles will be biopsied.
MelaFind® is indicated for use on clinically atypical cutaneous pigmented skin lesions with a diameter between
2mm and 22mm that are accessible by MelaFind®, sufficiently pigmented (i.e., not for use on non-pigmented or
skin-colored lesions), that do not contain a scar or fibrosis consistent with previous trauma, where the skin is intact
(i.e., non-ulcerated, non-bleeding lesions), that are more than 1cm away from the eye, do not contain foreign matter,
and are not on special anatomic sites (i.e., not for use on palms of hands, soles of feet, lips, genitals, and beneath the nails).