Combined 755nm Alexandrite Laser With Bipolar RF for Hair Reduction

Exclusion Criteria

• •1. Subject has only white, red, blond or grey hairs in the treatment areas
• •2. Subject has injury, scarring or infection in the treatment areas
• •3. Subject has a tattoo in the treatment areas
• •4. Subject is pregnant or is lactating or plans to become pregnant during their 16 month study period. Pregnancy will be assessed by question at screening
• •5. Subject is not willing to have long term hair loss in the treated areas
• •6. Subject is not willing to discontinue shaving treatment areas at least one week prior to treatment and follow-up visits
• •7. Subject has an active electrical implant anywhere in the body, such as a pacemaker, an internal defibrillator, insulin pump, incontinence device, etc
• •8. Subject is photosensitive due to having a condition such as porphyria, polymorphic light eruption, solar urticaria, lupus, etc
• •9. Subject has used Accutane or other oral retinoic acid therapy in the past 6 months
• •10. Subject has a known anticoagulation or thromboembolic condition
• •11. Subject is taking anticoagulation medication
• •12. Subject has a known history of hypertrophic or keloid scars following skin injury
• •13. Subject has known collagen vascular disease such as scleroderma, lupus, etc
• •14. Subject is immunocompromised (including HIV infection or AIDS) or currently using immunosuppressive medications
• •15. Subject had rotating type tweezer epilator treatment, or waxing within the last 3 months
• •16. Subject had electrolysis treatment over the treatment areas
• •17. Subject had any type of professional intense pulsed light (IPL), laser or RF hair removal in the treatment areas
• •18. Subject has any other condition which in the physician's opinion would make it unsafe for the subject to be treated
• •19. Subject has participated in a study of another device or drug within 1 month prior to enrollment or during this study
• •20. Subject has allergy to lidocaine