Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

Clinical Evaluation of LightSheer Duet 805nm HS Handpiece

• The study will re-confirm that the LightSheer Duet HS 805 nm handpiece is safe for removal of unwanted hair, and will result in hair removal and permanent hair count reduction.
• Twenty (20)subjects, Fitzpatrick Skin Type I-IV will be included in a single site.
• Each subject will receive five treatments at four to six week intervals and return for follow-up visits at three and six months after the last treatment for evaluation of the treated areas.

Inclusion Criteria:

1. Able to read, understand and provide written Informed Consent;
2. Healthy adult, male or female, 18 years of age or older with skin type I-IV;
3. Having a suitable treatment area for hair removal;
4. Able and willing to comply with the treatment/follow-up schedule and requirements;
5. 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:

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.