Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

Exclusion Criteria

• •1. Pregnant, expectation of pregnancy, postpartum or nursing (\<6 months);
• •2. Hormonal disorders that may affect hair growth;
• •3. Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
• •4. Livedo reticularis;
• •5. Uncontrolled systemic diseases such as diabetes;
• •6. Active infections in the treated area;
• •7. Dysplastic nevi;
• •8. Significant concurrent skin conditions or any inflammatory skin conditions;
• •9. Active cold sores, open lacerations or abrasions;
• •10. Chronic or cutaneous viral, fungal, or bacterial diseases;
• •11. Current cancer;
• •12. History of skin cancer or pre-cancerous lesions at the treatment areas;
• •13. Use of Accutane™ (Isotretinoin) within the past six month;
• •14. Keloid formation in the treatment area;
• •15. Tattoos in the treatment area;
• •16. Bleeding coagulopathies or use of anticoagulants;
• •17. Auto-immune disorders;
• •18. Erythema ab igne, when identified treatments should be discontinued;
• •19. Photosensitivity disorder that can be exacerbated by laser or intense light;
• •20. Herpes simplex in the treatment area;
• •21. Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
• •22. Poor wound healing;
• •23. Sunburns;
• •24. Unable or unlikely to refrain from artificial tanning, including the use of tanning booths, prior (at least a week) and during the course of the evaluation;
• •25. Prior skin treatment with laser or other devices on the same treated areas within the last six months prior to study enrollment or during the course of the study.