Open-label, Prospective, Multicenter Study to Evaluate the Cutera Excel V™ Laser and a Micro-Lens Array Attachment

Exclusion Criteria

• •1. Participation in a clinical trial of another drug, or device administered to the treatment area, within 3 months prior to enrollment or during the study.
• •2. Any type of prior cosmetic treatment to the target area within 6 months of study participation, such as laser procedures, facial fillers, toxins and those used for general aesthetic correction.
• •3. Use of prescription topicals in the treatment area within one month prior to treatment or use of topical agents one week prior to treatment that may cause facial sensitivity.
• •4. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including but not limited to, open lacerations or abrasions, hidradenitis, rash, infection , or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion).
• •5. Pregnant and/or breastfeeding, or planning to become pregnant.
• •6. Significant concurrent illness, such as diabetes mellitus, immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or using immunosuppressive medication.
• •7. Hypersensitivity to light exposure.
• •8. Any use of medication that is known to increase sensitivity to light according to the Investigator's discretion.
• •9. History of keloid scarring, hypertrophic scarring or abnormal wound healing or prone to bruising.
• •10. Has a history of squamous cell carcinoma or melanoma in the treatment area.
• •11. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
• •12. A history or active skin condition that in the opinion of the Investigator may interfere/confound with the treatment.
• •13. History of connective tissue disease, such as systemic lupus erythematosus or scleroderma.
• •14. 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.
• •15. History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation, or any that are considered not acceptable by the study investigator.
• •16. Has used oral isotretinoin (Accutane or therapeutic vitamin A supplements of ≥ 10,000 units per day) within 12 months of initial treatment or plans on using during the course of the study (note: skin must regain its normal degree of moisture prior to treatment, e.g. lack of noticeable skin flaking and peeling).
• •17. Excessively tanned or active sun tan in facial area to be treated, or unable/unlikely to refrain from tanning during the study.
• •18. Excessive facial hair in the area to be treated (beards, sideburns, and/or moustache,) that would interfere with diagnosis, assessment, and treatment.
• •19. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study, including excessive alcohol or drug abuses, or a condition that would compromise the subject's ability to comply with the study requirements.