Friday, February 16, 2007

LaserComb For Your Chrome Dome

Filed under: Dermatology , Pseudoscience Fridays

Holy Shatner! The FDA has actually approved the HairMax Lasercomb for thicker, fuller hair. Obviously, the HairMax employee who put together that application was not the same one in charge of their cheesy websites and press releases:

And laser energy is also coherent. All energy consists of waves of energy and in the light bulb these waves are not organized or in sync with each other. The waves of light energy produced by a laser are synched or in phase with each other. These characteristics make laser energy a truly unique form of light energy.

LLLT is used throughout the world and for the energy produced by the HairMax LaserComb there are no reported or known adverse side effects.

Here's the data the approval was based on (it's not in any peer-reviewed journal we could find, and the fact that this page refers to it as a 'miracle' makes me question its independence):

For the FDA submission, Lexington conducted an extensive clinical study in four different locations across the United States. The study concluded that 93% of the participants (ages 30-60) using the HairMax LaserComb had an increase in the number of terminal (thick) hairs. The average number of terminal hairs per square centimeter increased by 19 hairs/cm2 over a six-month period. During the study, there were no reports of serious adverse events. The number and types of adverse events were similar in both the active and placebo groups.

How does this miracle work? Fortunately, treatments using the HairMax LaserComb are easy to administer, only 10 to 15 minutes three times per week, and the laser device is convenient to use in the comfort and privacy of your own home. HairMax has been precision-engineered into a compact device about the size of a curling iron. Just pass it through your hair three times a week for about ten minutes for optimal results. Of course, everybody is unique and results differ among individuals, but anecdotal trials have shown that over 90% of users experience positive benefits and are satisfied with the results they achieve. In general, about 45% of users see noticeable improvements in as little as 8 weeks of treatment. Another 45% realize benefits from 8 to 16 weeks. A small group of users take longer, seeing results around 16 weeks.

So after six months of 3-times-a-week use, laser users reported 19 more thick hairs per square centimeter, compared to sham groups. All this time, we thought they were pulling the wool over our eyes.

The lasercomb retails for over $600.

More from the FDA (pdf) and Lexington LaserComb, an apparently legitimate company...

Flashback: Smoke and Mirrors

email this article to a friend      print this!           comments and peer reviews (5)






replies: 5 comments
Open comments are not moderated, although abusive and vulgar remarks may be deleted. Opinions expressed do not necessarily reflect the views of Medgadget.com. Please consult our disclaimer.

Are you saying the FDA can be bought??????????????


Posted by: Barky
on February 16, 2007 04:44 PM GMT

Well, what happened was that the device received a what is known as a 510 approval, which means they did not have to show efficacy. They only had to show that the device is nothing fundamentally new and the same technology was already used prior to 1974 in other devices.
This was not approval based on the study conducted, although the study was conducted.


Posted by: Bruder
on February 17, 2007 11:30 AM GMT

Your statement seems incorrect. According to the FDA's website, they did have to show efficacy:

**********
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA
**********


Posted by:
on March 17, 2007 11:56 AM GMT

This is a load of rubbish... Even the company has no idea.. Look at the smoke WOW its a smokey laser. Is that one faulty or what? :>)

If you really want to know how pathetic this company is... look at this link from THEIR site :>)

http://www.lasercomb.net/CustomerService.aspx#distributors

Look at what their inventor in Australia has done Just Click... They are toteing the HairPRO the biggest load of garbage with 36 christmas tree lights ... and they are toteing this on the hairmax lasercomb site?? HELLO!!!!

Click the other distributors... most dont exist.. or dont even sell this hideous gadget... Steer CLEAR!!

Dick


Posted by:
on June 24, 2007 04:42 AM GMT

I saw the money back guarantee and thought it was worth a try. Of course there has been no improvement in my hair. But, now I will have to pay a $75.00 restocking fee. Anyone know a way around this?
Thanks.


Posted by: geewiz
on August 18, 2007 06:24 AM GMT

add a comment
html tags: <b>, <i>, and <a>
examples: <b>Bold</b> <i>Italic</i>









Remember personal info?
(anonymous comments allowed)



click to make your selection boldclick to make your selection italicclick to add a link


Verification (needed to reduce spam):




Click the "Post" button only once!