510k FDA clearance allows the company to legally state that the HairMax Laser Comb is now clinically proven to promote hair growth in males with androgenetic alopecia.

However, the $64,000 question that still plagues many well known hair loss experts is, can the HairMax Laser Comb grow visible, appreciable hair or is this FDA “clearance” based solely on slight changes in hair characteristics and microscopic photographic evidence?

Does the HairMax Laser Comb truly help hair loss sufferers, or is Lexington International just helping themselves to an even bigger piece of the $3.5 billion a year hair loss industry pie?

On Sunday October 7th, 2007 The Bald Truth Radio Show invited Lexington International’s CEO and inventor of the HairMax Laser Comb, David Michaels along with Randy Veliky, Lexington’s COO to answer some difficult questions about their product as well as to speak with callers who purchased The HairMax Laser Comb.

Issues discussed on the program include:

• The difference between FDA approval and FDA clearance

• Specifics of clinical study results.

• Why the FDA only granted the HairMax Laser Comb clearance for males?

• Does the HairMax Laser Comb really stop hair loss and regrow hair?

• Is their a difference between the HairMX laser comb and other LLLT hair growth devices?

• The validly of Lexington’s before and after photos.

• Inventor of the Hairmax Laser comb David Michaels’ credentials and much, much more.

Listen To The Show:

The Bald Truth Segment One

The Bald Truth Segment Two

I’ve had a thinning spot on the top of my head for almost 10 years.

I’ve been using Minoxidil and Finasteride since 2004, and the combination seems to be working. I may have a little regrowth, but the important thing is that the spot seems not to be growing.

My question is this: Is there anything else I should be doing? The whole “Laser combs” thing sounds like a fly-by-night industry to me - do they really work?

Thanks in advance.

– Keith in NYC

Answer:

Hi Keith. You have a good question which has a highly debatable answer. The main idea behind the “laser comb” is basically that it increases the circulation in the area where the low level laser light therapy is used. This increase in blood flow to the follicles, according to the laser comb promoters, has a positive effect on the follicles which causes an overall decrease in hair loss.

I have a problem with the supposed mechanism by which the laser comb works to prevent hair loss. While I don’t dispute the comb’s ability to cause a transient increase in blood flow, I do feel that this does not treat the underlying cause of the hair loss. In my opinion, hair loss is not the result of a lack of blood supply to the scalp but rather, it is a result of the negative effects of DHT binding to the follicle receptors. This concept is widely accepted as the root of male pattern baldness and is the reason why finasteride helps prevent hair loss (by lowering the DHT level). Since the laser comb therapy does nothing to change the level of DHT at the receptor site, I do not feel that it has much more than a placebo-type effect on hair loss.

In practice, I have not heard many good things about laser comb therapy. I have had a few patients state their belief that the comb has helped stop their hair loss, but these are usually patients who are also taking finasteride. The problem in this lies in the fact that if a patient is taking two treatments at the same time, it is difficult to gauge the overall effects of each individual treatment. Basically, it is hard to show that the comb had any beneficial effects, as the hair loss prevention may have been attributable only to the finasteride.

I am going to point out one more issue regarding the comb. The laser comb does have FDA approval, though this may be misleading. The technology behind the laser comb has been around for decades. The FDA approval for this device is not based on any amazing new studies. Rather, it has been approved because the technology pre-dates when the FDA began its supervisory role. Therefore, this device did not have to pass through today’s stringent FDA approval process.

Brandon Ross, MD
http://www.rmhri.com
IAHRS Recommended Hair Transplant Surgeon