A Clinical Evaluation of a Novel Multi-Wavelength Laser for Benign Pigmented Lesion Removal

Exclusion Criteria

• •Participation in a clinical trial of another device or drug within 6 months prior to enrollment or during the study.
• •Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as chemical peel, laser or light-based procedure, or surgery.
• •Presence of pre-malignant or malignant lesion in the treatment area (such as, but not limited to pigmented actinic keratosis, lentigo maligna or lentigo maligna melanoma) or history of a pre-malignant or malignant lesion in the treatment area.
• •Shows signs of actinic bronzing and/or excessively tanned in areas to be treated, and unable or unlikely to refrain from tanning during the study (for example, subject's occupation requires regular sun exposure).
• •Skin abnormalities in the target area, e.g., cuts, scrapes, wounds, scars, large moles.
• •Pregnant and/or breastfeeding.
• •Having an infection, dermatitis or a rash in the treatment area.
• •Significant concurrent illness, such as diabetes mellitus or cardiovascular disease, e.g., uncontrolled hypertension.
• •Suffering from coagulation disorders or taking prescription anticoagulation medications.
• •History of keloid scarring, hypertrophic scarring or of abnormal wound healing.
• •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
• •History of vitiligo, eczema, or psoriasis.
• •History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• •History of seizure disorders due to light.
• •Any use of medication that is known to increase sensitivity to light according to Investigator's discretion.
• •History of disease stimulated by heat, such as recurrent herpes simplex and/or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen
• •History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer.
• •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
• •Systemic use of corticosteroid or isotretinoin within 12 months of study participation.
• •Anytime in life, having have used gold therapy (gold salts) for disorders such as rheumatologic disease or lupus.
• •Current smoker or history of smoking within 6 months of study participation.
• •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.