Post-Approval Study of MelaFind

Inclusion Criteria:

The lesion is pigmented (i.e., melanin, keratin, blood)
Clinical management of the lesion by the examining dermatologist is either biopsy of the lesion in toto, or 3-month follow-up of the lesion
The diameter of the pigmented area is between 2 and 22 millimeters
The lesion is accessible to the MelaFind hand-held imaging device
The patient, or a legally authorized representative, has consented to participate in the study and has signed the Informed Consent Form

Exclusion Criteria:

The patient has a known allergy to isopropyl alcohol
The lesion has been previously biopsied, excised, or traumatized
The skin is not intact (e.g., open sores, ulcers, bleeding)
The lesion is within 1 cm of the eye
The lesion is on mucosal surfaces (e.g., lips, genitals)
The lesion is on palmar hands
The lesion is on plantar feet
The lesion is on or under nails
The lesion is located on or in an area of visible scarring
The lesion contains foreign matter (e.g., tattoo, splinter, marker)