HairMax LaserComb now FDA approved -- no, really

Brace yourself Jack... remember the HairMax LaserComb? Yeah, well it's now FDA approved. Seriously, in the FDA trial some 93% of the participants saw an increase in hair density with an average increase of 19 hairs/cm. Of course, that stamp of approval doesn't necessarily mean those lasers will restore your hair, but at least it's not likely to singe the tuft you've got left. Just remember, the FDA also approved Olestra which can cause orificial leakage. Now go ahead, pony-up the $545 required to try 'er out. We sure as hell won't be going hands-on with this one.

[Via Physorg.com]

[Mathew Kunst @ Feb 16th 2007 10:30AM]

Couldn't I just rub my laser mouse on my bald spot and save $530???

[Brian @ Feb 16th 2007 10:43AM]

I always thought these were bogus. It turns out they work after all?

My world is crumbling around me.

[Rocket Punch @ Feb 16th 2007 11:15AM]

I want freaking lasers attached to the comb!

[Mile @ Feb 16th 2007 11:24AM]

Lasers - Is there anything they can't do?

[Matt Hadder @ Feb 16th 2007 12:09PM]

If it works, even to a small degree, its well worth it.
I had been using a 'Row-gane' monoxidile hair regrowth product for 8 years before the cumulative side effects became too much. (chest pain, dizzyness, weight gain etc etc) and at $30 to 50 a month x 8 years...

[Kurt @ Feb 16th 2007 12:56PM]

I actually saw this on a TV show....they did a 1 year study with Rogain, Propecia, the laser comb, avacor, and some shampoo that they sell in salons.

As expected propecia made the most difference and then they said it was a tie for second with the laser comb and Rogaine. They said the hair was more like the other hair with the comb while Rogaine was real thin and whispy hair.

[Cold Laser @ Feb 16th 2007 1:06PM]

The perception of any laser-based technology seems to be an ignorant one across the board. The truth of the matter is that LLLT (low level laser therapy), technology which this comb uses, has been FDA approved for years. Many sports physicians use LLLT to help the process of healing and pain relief of muscle and ligament tissue and many other ailments. There is even another company that uses this same hair rejuvenation claim and technology in California (http://www.hairsolutionsca.com/is_this_right.htm). I'm surprised by the lack of laser knowledge from a technology-based website.

[Matt Blatz @ Feb 16th 2007 5:33PM]

Try this out... www.current-technology.com for hair info.

[booger62 @ Feb 16th 2007 10:28PM]

Don't they mean anal seepage, when they say orificial leakage?

[Enigma @ Jun 9th 2007 7:29PM]

So great, you have more hair but your butt leaks, sounds like a crappy trade off to me.

[Majd @ Feb 17th 2007 9:48AM]

Density is measured in hairs/cm^2, not hairs/cm

[Daniel Rutter @ Feb 17th 2007 12:56PM]

There was no "FDA trial".

The AP piece clearly states that the manufacturers (say they) did a trial, which means nothing unless someone else replicates the results (don't hold your breath for that to happen...). And, separately, the FDA have approved the device, which just means they've verified that it seems unlikely to blind people, catch fire, cause botulism, et cetera.

Regulatory authority approval for oddball medical devices usually only means they've been tested for basic safety. Sometimes all it means is that the manufacturers have paid to be put on a list.

[Sina @ Feb 17th 2007 10:04PM]

It really is only FDA approved as being safe. Which would make this article completely inaccurate. Maybe someone from engadget should have it fixed/removed?

[Frank @ Mar 30th 2007 7:10AM]

You guys have no clue to the FDA approval process. They must, and did, review the Lexington trial data. They make no judgement on that data, but remember, they are approving it as a device to "regrow hair". That is kind of doublespeak...but my point is, they DID review the Lexington data.

[Scott @ May 7th 2007 9:04PM]

Daniel and Sina, don't be ignorant. Here is the FDA approval: www.fda.gov/cdrh/pdf6/K060305.pdf It clearly states "the LaserComb satisfies FDA's substantial equivalence with respect to both the INTENDED USE and technological characteristics." The "intended use", as stated in the document is "to promote hair growth in males with androgenetic alopecia who have NOrwook Hamilton Classificaitons of IIa to V and Fitzpatrick Skin Types I to IV." So the LaserComb has clearly been FDA-approved to grow hair in most balding white men.

[Enigma @ Jun 9th 2007 7:29PM]

Ya'll the FDA has approved so much crap in the last 10 years that 1/2 of it has been pulled already & the companies sued for everything from fraud to death from the products. Get a clue, the FDA is in it for the money just like everything else. Men should figure out that women don't love them for their hair. Trust me, I know. It's what between you ears, your legs, and your checkbook covers that we are concerned about, not what's on top of your head. LOL

[Arthur @ Jun 29th 2007 1:08PM]

I've spoken to several people about this new laser hair growth technology. A lot of them said that although it's not FDA approved yet, the Hair Rejuvenator (hairrejuvenator.com) is a much better device because it has 9 actual laser modules. The HairMax only has one module deflected into 9 beams.

[Jason @ Aug 26th 2007 11:51PM]

I just bought one and I am starting this week. I will keep this site informed of my progress.

[gmal @ Sep 26th 2007 2:45PM]

hey guys can you tell me where can i buy the laser comb in india??

[Mike @ Jan 8th 2009 11:52PM]

I just got a Hairmax comb a few weeks ago. Even after just a few weeks I'm starting to see and feel a difference. I noticed the hair on my entire head is looking a bit darker and thicker, unlike Rogaine's results which don't do much for the hair on the frontal area. I've tried Propecia and Rogaine. Both failed me. Propecia zapped my mojo. It took about a year to get it back after discontinuing use. Some guys don't have any issues with it. Rogaine made my chest hurt after 5 about years of use. I felt like I couldn't catch my breath and my heart was going to explode. Turns out Rogaine dilates all the vessels in your body and your blood pressure drops. To compensate the heart works extra hard to keep up the pressure. Eventually the heart starts to hurt from being overworked.

[alejandro lecours @ May 9th 2009 4:16PM]

I have been using a device called the lasercomb(by hairmax) for almost 6 months. Its a product that is supposed to stop hair loss. I used it as indicated in its instructions, 3 times a week and each session not to exceed 10 to 15 minutes. It said to always leave at least 1 day of non use between each treatment which I did. On May 4 2009 I felt dizziness and difficulty to speak and also I felt that I was going to faint. I was rushed to a hospital where I live in Caracas Venezuela, and was addmitted to the emergency room. Upon arrival my blood pressure was very low, 9 over 5 as I recall. All sorts of tests were performed, bllod tests, urine tests, electrocardiogram, cat scan, etc. and all tests were perfectly normal. I described to my doctor that I felt a strange tingling or sensitivity on the top of my skull. When I touched the top of my head I felt an elongated lump on the very top of my skull. I knew that this lump was something new that was definitely not there before. The doctor said he could not conclude if the lasercomb had caused the problem but he recommended me to inmediately stop using it. I did stop using it and the elongated lump on the top of my skull decreased in size each day, and today only 4 days after the episode that sent me to the emergency room its about 80% vanished and I now no longer feel the sensitivity I had been feeling for some time on the top of my skull(which was the spot where I had most intensely focused the use of the lasercomb). I now feel fine but am convinced that the lasrcomb has serious life threatening side effects.