Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

Inclusion criteria

• Able to read, understand and provide written Informed Consent;
• Healthy adult, male or female, 18 years of age or older with skin type I-IV;
• Having a suitable treatment area for hair removal;
• Able and willing to comply with the treatment/follow-up schedule and requirements;
• Women of child-bearing potential (women who have not had a hysterectomy, bilateral oophorectomy or are not postmenopausal) are required to be using a reliable method of birth control at least three months prior to enrollment and throughout the course of the study.

Exclusion criteria

• Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
• Hormonal disorders that may affect hair growth;
• Immunosuppressive diseases, including AIDS and HIV infection, or use of immunosuppressive medications;
• Livedo reticularis;
• Uncontrolled systemic diseases such as diabetes;
• Active infections in the treated area;
• Dysplastic nevi;
• Significant concurrent skin conditions or any inflammatory skin conditions;
• Active cold sores, open lacerations or abrasions;
• Chronic or cutaneous viral, fungal, or bacterial diseases;
• Current cancer;
• History of skin cancer or pre-cancerous lesions at the treatment areas;
• Use of Accutane™ (Isotretinoin) within the past six month;
• Keloid formation in the treatment area;
• Tattoos in the treatment area;
• Bleeding coagulopathies or use of anticoagulants;
• Auto-immune disorders;
• Erythema ab igne, when identified treatments should be discontinued;
• Photosensitivity disorder that can be exacerbated by laser or intense light;
• Herpes simplex in the treatment area;
• Use of medications, herbal supplements, perfumes or cosmetics that may affect sensitivity to light;
• Poor wound healing;
• Sunburns;
• 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;
• 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.