| Eligibility |
Inclusion Criteria:
1. Able to read, understand and provide written Informed Consent;
2. Subject has black or dark brown terminal hairs in the areas to be treated.
3. Terminal hair density requirement of greater than 15 hairs within the hair count site
(3x3 cm area) as determined by manual hair count performed by the study investigator.
4. Healthy adult, male or female, 21 years of age or older with skin type V-VI;
5. Having a suitable treatment area for hair removal;
6. Able and willing to comply with the treatment/follow-up schedule and requirements;
7. 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. Subject has light ,gray terminal or fine hairs in all/some parts of the treated area;
2. Pregnant, expectation of pregnancy, postpartum or nursing (<6 months);
3. Hormonal disorders that may affect hair growth;
4. Immunosuppressive diseases, including AIDS and HIV infection, or use of
immunosuppressive medications;
5. Livedo reticularis;
6. Uncontrolled systemic diseases such as diabetes;
7. Active infections in the treated area;
8. Dysplastic nevi;
9. Significant concurrent skin conditions or any inflammatory skin conditions;
10. Active cold sores, open lacerations or abrasions;
11. Chronic or cutaneous viral, fungal, or bacterial diseases;
12. Current cancer;
13. History of skin cancer or pre-cancerous lesions at the treatment areas;
14. Use of Accutaneâ„¢ (Isotretinoin) within the past six month;
15. Keloid or Hypertrophic scar formation in the treatment area;
16. Tattoos in the treatment area;
17. Bleeding coagulopathies or use of anticoagulants;
18. Auto-immune disorders;
19. Erythema abigne, when identified treatments should be discontinued;
20. Photosensitivity disorder that can be exacerbated by laser or intense light;
21. Herpes simplex in the treatment area;
22. Use of medications, herbal supplements, perfumes or cosmetics that may affect
sensitivity to light;
23. Poor wound healing;
24. Sunburns;
25. Unable or unlikely to refrain from artificial tanning, including the use of tanning
booths, prior (at least a month) and during the course of the evaluation;
26. 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.
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