"Low-level laser light has also been found to have biomodulating effects on human hair and hair follicles. Clinical studies have shown that low-level laser light is effective both cosmetically and physiologically in hair restoration. The cosmetic effects include improvements in hair sheen and strength, characteristics that enhance the perception of "fullness" in overall hair appearance. Physiologic effects on hair follicles observed in both men and women include (1) prevention of hair loss, and (2) stimulation of hair regrowth in areas of hair loss.The device is accepted as a Medical Device in Canada, and advertising is allowed to make therapeutic claims that it (1) increases strength of scalp hair in men and women, (2) prevents scalp hair loss in men and women, and (3) causes regrowth of scalp hair in men and women. In the United States it is accepted by the Food and Drug Administration (FDA) for use as a Cosmetic Laser Product.

In the most recently conducted FDA clinical trials of the device, patients studied were men and women with thinning hair in the scalp area. The patients received two low-level laser light treatments per week over a six-month period. Results have shown:

·  100% of men had stabilization of hair loss in frontal and vertex (top of the head) areas;

·  84.6% of men had hair regrowth (11% of more from baseline) in the frontal area;

·  82.8% of men had hair regrowth (11% or more from baseline) in the vertex area;

·  87.5% of women had stabilization of hair loss in the frontal area;

·  100% of women had stabilization of hair loss in the vertex area;

·  75% of women had hair regrowth (11% or more from baseline) in the frontal area; and,

·  96.4% of women had hair regrowth (11% or more from baseline) in the vertex area.