Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions

Inclusion Criteria

• Male or Female
• Age 21 to 70
• Fitzpatrick Skin Type I to V
• Willingness to have test spots and up to three (3) skin resurfacing treatments on the face
• Presence of pigmented lesions to be treated off the face must be rated at baseline as moderate or higher per Investigator or study staff
• Provide signed informed consent to participate in the study
• Adhere to study treatment and follow-up schedules
• Willing to have hair removed from the intended treatment area prior to treatment and/or photography
• Avoid sun exposure to all treated areas and use of sunscreen with sun protection factor (SPF) 30 or greater throughout the duration of the study
• Adhere to post-treatment care instructions
• Allow photography of treated areas and to release their use for scientific and/or promotional purposes

Exclusion Criteria

• Pregnant, planning to become pregnant, or breast feeding during the study
• Allergy to lidocaine or similar medications
• Excessively tanned skin in the intended treatment area
• Open wound or infection in the intended treatment area
• Tattoo(s) or permanent make-up in the intended treatment area
• Skin condition in the intended treatment area that could interfere with treatment or evaluation of safety or efficacy
• Presence or history of melasma
• Presence or history of skin cancer within the treatment area(s)
• History of keloid or hypertrophic scar formation
• History of herpes simplex virus (HSV) or similar condition in the intended treatment area unless treated with prophylactic medication
• Diagnosed coagulation disorder
• Immunosuppression
• Presence of any medical condition that in the opinion of the Investigator could impair healing or outcome as a result of treatment
• Use of systemic retinoid therapy (e.g. Accutane) during the past six (6) months
• Use of topical retinoid therapy in the intended treatment area during the past two (2) weeks
• Use of oral corticosteroid therapy during the past four (4) weeks
• Prior skin resurfacing treatment, such as surgery, light, laser or radiofrequency (RF) procedures in the intended treatment area during the past six (6) months
• Prior injectable dermal fillers in the intended treatment areas within the past twelve (12) months
• Prior injectable toxins (Botox) in the treated areas within the past three (3) months
• Subjects who in the opinion of the Investigator are unwilling or unable to adhere to the study requirements, or who are otherwise not a good candidate for the study