Evaluation of the Lutronic LaseMD System for the Treatment of Benign Pigmented Lesions
The Lutronic LaseMD Laser System will be evaluated for the treatment of benign pigmented lesions.
• Male or female, age 18 years and older.
• Subject in good health.
• Fitzpatrick Skin Type I to VI.
• Presence of benign pigmented lesions on décolleté, arms, hands, face, and/or neck.
• Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
• Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
• Subjects of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the Screening Visit and be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
∙ Postmenopausal for at least 12 months prior to study;
‣ Without a uterus and/or both ovaries; or
‣ Bilateral tubal ligation at least six months prior to study enrollment.
• Absence of physical or psychological conditions unacceptable to the investigator.
• Willingness and ability to provide written consent for study-required photography and adherence to photography procedures (i.e., removal of jewelry and makeup).
⁃ Willingness and ability to provide written informed consent and HIPAA authorization prior to performance of any study-related procedure.