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Hair loss

HairMax Laser Comb receives FDA clearance as hair regrowth device for humans

Tuesday, February 27, 2007 by: David Gutierrez, staff writer
Tags: hair loss, hair regrowth, male pattern baldness


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(NewsTarget) The FDA has approved the HairMax Laser Comb as the first drug-free hair regrowth device for at-home use. The Laser Comb, which is only the third hair regrowth product to receive FDA approval, is manufactured by Lexington International, LLC, based in Boca Raton, Fla.

Jump directly to: conventional view | alternative view | bottom line

What you need to know - Conventional View

• Approximately fifty-five million men in the United States are affected by hair loss.

• The HairMax Laser Comb uses lasers to stimulate the hair follicle and encourage new growth. According to studies conducted by Lexington, the device increased the number of thick hairs in 93 percent of users aged 30 to 60. The average increase in hair density was 19 hairs per square centimeter.

• Side effects from the product's use were similar to those from placebo tests. No serious adverse effects were reported.

• Lasers have been used for hair regrowth treatments for more than 18 years, but the Laser Comb is the first device that can be used at home. Other laser treatments use large devices called Laser Hoods, which must be used at a clinic and may cost thousands of dollars per visit.

• The hand-held Laser Comb is about the size of a curling iron and retails for $645. Lexington recommends its use for 10-15 minutes, three times a week.

• Quote: “The HairMax LaserComb is a method of treatment that can be of great help to men of all ages suffering from hair loss. With the FDA clearing the HairMax LaserComb as a medical device, it offers an attractive option for hair growth for medical practitioners.” - Dr. Matt Leavitt, Chief Medical Advisor to Lexington

What you need to know - Alternative View

Statements and opinions by Mike Adams

• Natural sunlight emits the same wavelengths of light produced by hair regrowth laser devices, yet it costs nothing. Exposing your head to sunlight is a natural way to support natural hair growth and boost vitamin D synthesis at the same time. Unfortunately, most people with hair growth challenges cover their heads when outside, blocking all sunlight. The advantage of the HairMax LaserComb is that it can be used privately at home, even when the sun isn't shining.

• Lower cost phototherapy devices using LED lights (usually in the 650nm - 750nm range) can also help regrow hair and even accelerate the healing of wounds, although most such devices are not yet FDA approved for such uses.

• Phototherapy is an emerging field of medicine, and it's good to see the FDA finally offering a small bit of recognition for the medical use of healing light. Most of conventional medicine, however, continues to deny that sunlight, laser light or UV light has any healing potential whatsoever.

• In 2004, the FDA attacked an innovative company called, "Light Force Therapy" for selling infrared LED light devices for treating conditions "not approved by the FDA." (Click here to read the FDA warning letter.) Light Force Therapy no longer appears to be in business (the FDA was apparently successful in putting this company out of business.)

• Yet the FDA gave approval to the Warp 10 LED device which does essentially the same thing.

Bottom line

• The HairMax Laser Comb has been approved by the FDA as a treatment for hair loss and is available for purchase.

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