Federal regulators have approved a comb that, drawn across a balding pate, can restore real hair.

The manufacturer, Lexington International LLC, calls the handheld laser device the Hairmax Lasercomb, which the company said Thursday increases the numbers of thick hairs on the scalp, according to 26-week clinical trials.

The Food and Drug Administration's test report said subjects who used the treatment "had significantly greater increases in mean terminal hair density" than those who used placebo in the tests.

As the device's name suggests, it combines a low-level laser with a comb. When drawn through the hair, the laser strikes the scalp to promote hair growth, according to the company.

The device, sold on the Internet for $545, is the only drug-free product meant for home use in combating hair loss that's won the endorsement of the Food and Drug Administration, the company said.