Clinical Evaluation to Assess the Safety and Efficacy of GentleMax Pro/ GentleMax Pro Plus
Demonstrate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (PFB), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. Evaluate GentleMax Pro Plus™ laser system for the clearance of acne.
• At least 18 years of age or older
• Willingness to provide signed, informed consent to participate in the study
• Presence of unwanted hair, moderate or greater benign pigmented lesions, active acne, vascular lesions, nails affected with onychomycosis, and/or wrinkles assessed as Fitzpatrick Wrinkle and Elastosis Score (FWS) \>/= 1
• Willingness to adhere to study treatment and follow-up schedule
• Willingness to adhere to post-treatment care instructions
• Willingness to allow photographs and/or video of treated areas, and to release their use for scientific/educational and/or promotional/marketing purposes
• Willing to abstain from any other procedures, medications or topicals in the study treatment areas for the duration of the study which the investigator deems would interfere with the study