FDA Warns HairMax LaserComb Makers About Illegal Sales of Non-FDA Cleared Devices

Los Angeles – U.S. Regulators have warned Lexington International, the makers of the highly touted and controversial HairMax LaserComb, to shape up or ship out.

In an FDA warning letter issued to David Michaels, Managing Director of Lexington International, LLC on May 22, 2008, FDA inspectors cite that the HairMax LaserComb® Premium and SE models, that are currently being sold to the public, differ from the cleared HairMax LaserComb in dose rate, method of delivery, and/or treatment parameters. According to the FDA these changes could significantly affect the safety or effectiveness of these devices and therefore, pursuant to 21, CFR 807.81 (a)(3)(i), new 510(k) submissions are required in order to legally market these devices.

Interestingly enough HairMax LaserComb makers warn consumers about purchasing fraudulent, or less than effective laser devices on their own marketing website.

Here’s what it states on the HairMax website:

As a consumer, we suggest that you educate yourself thoroughly before making a purchase or utilizing a laser device.  Make no mistake: Using lasers for any reason is a very serious medical undertaking which, if not administered under proper safety guidelines, can be risky. At best, you may be buying a laser device and spending time using it, only to receive minimal if any results.

Again, at Lexington we care about your safety and your right to be educated as a consumer.
And remember: CAVEAT EMPTOR; BUYER BEWARE.

Included on their website is an FDA warning Letter issued to a competitor just two months before U.S. Regulators issued a warning to Lexington International, LLC.

The American Hair Loss Association does not currently recommend the HairMax LaserComb for the prevention and treatment of hair loss.

Caveat Emptor Indeed.

Spencer Kobren
Host of The Bald Truth Radio Show
Founder, American Hair Loss Association
Founder and Director of Consumer/Patient Affairs, International Alliance of Hair Restoration Surgeons (IAHRS.ORG)

**Please also be aware that this letter was issued on May 22, 2008, and at this time we do not know if Lexington International, LLC has since acquired the appropriate FDA clearance to market and sell the HairMax LaserComb® Premium and SE models.

To Read FDA Warning Letter Visit:

Lexington International, LLC 22-May-08

Listen To an Interview With David Michaels:

David Michaels Defends The Efficacy of The HairMax Lasercomb

 

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18 Comments

  • Dave Solazzo

    Wow…that’s big news! So what happens to all the people who bought the Premium and SE models of the comb? Can they exchange them or get their money back?

  • Spencer Kobren

    I couldn’t believe what I was reading! I wouldn’t hold your breath waiting for a refund people. Just another day in “the business of Hair”.

  • Hey Spencer,

    Have been a loyal listener to your show for quite some time and I love your site. This whole lasercomb thing has got me going nuts.

    I’m a technician for a very popular hair transplant doctor in NY and word around the industry is that this David Michaels has not made a lot of friends. Actually, he’s made enemies.

    Still, the question remains, what about the people who bought his SE model that was supposedly cleared according to his site and sales people? What becomes of their money? How has a scam of this magnitude been able to take place? How will the US government allow it?

    He owes a lot of people a lot of money. Do I smell class action??? Is that even possible?

  • Tee Jay

    I had never realized there was this much “talk” about laser therapy as a potential treatment for hair loss, probaly because I never looked at the possibility of laser therapy to deal with my own hair loss. I went with surgery with an IAHRS doc instead (and love it).

    But as a technical guy myself (engineering) that likes to have some basic fundamental understanding of things, it seems odd that lasers have been touted as a treatment route. I just don’t get it? Why would a laser pulse help hair follicles continue to live and possibly grow hair? Propecia as a treatment to hair lss is obvious — it blocks DHT. Surgery is also obvious — DHT-resistant hair follicles are cosmetically redistributed on the scalp. But what are the very basics of laser therapy?

    Tee Jay

  • Destin

    Does anyone know how long they have been seeling these “non FDA cleared” lasers.. I bought mine in July of 2007, mine says it has the 510k laser class thing on it.

  • If anyone bought an SE model since January of 2007 up until they changed their Web site in June, then you were mislead. They clearly stated that the SE model was “equivalent” in clearance to the premium mode.

    I can only hope that people contact the FDA about this…Michaels (the owner) has probably made millions off of this scam. Like Spencer said, you can forget about contacting the company for your money back. That’s the hair loss business…

    Get a good transplant and forget about this laser business. As a tech, believe me, you’d be shocked at the results that 90% of even the baldest people walk away with. It’s not Joe Biden by a long shot ….lol!

    Hey Spence, why don’t you ask him to come back on the show and ask him why he was selling the SE as equivalent in clearance to the premium. Then ask him why he made a design change that could have been potentially dangerous without telling people or getting clearance? Is this guy a joke? You know, you’ve spoken with him. I only know of his reputation, and it’s not pretty.

  • chris

    That’s interesting, because if you go to the Hairmax site, and order a premium model, they state that it was the premium model that was cleared by the FDA. If this is true, I wonder why Lexington hasn’t responded to the warning letter.

  • Spencer Kobren

    We’ll be checking it out guys. The truth is, in my opinion, it appears that the the HairMax laserComb people were intentionally misleading the public. This is a really big deal!

  • Yes, they have mislead people intentionally. I think this is just the beginning for them. As a tech and a consumer (I’ve had my own doctor transplant me) I just wonder how they could do this. They seemingly intentionally went out of their way to lie about the SE being equivalent to the premium in clearance just because of the price point.

    When they got in to a little trouble they took the SE down, but you know what? If you had called in and asked for it (which I did) after the clearance, you would have found out that they were still pitching the SE as “cleared.”

    Not only that, but the model I got, which was a premium has the 9 individual beams, precisely what they are in trouble for. Now I’m afraid that this thing can cause me brain cancer. Not only will I not use it (my boss told me not to waste my money in the first place), but I want my money back.

    Lexington really made a big to do about this clearance thing by the FDA. And much to my chagrin I bit. So too did so many others.

    Please talk about this, Spencer. The doctor I work for was absolutely right when he told me to stay far away from them….

    It sucks to be disappointed, Spencer. It really does. I love my transplant and love what I help do for others, but this is really not fair to anyone.

  • Ha…Funny…The anti spam word I just put in was propecia. I feel like ive just been kicked in the balls! I could have spent my $500 on a yearly treatment of propecia then recently buying this stupid machine beaming lasers in my head. Awesome news!

  • Destin

    If this is just the SE models, then I should be safe, I have been using the Premium (9 laser beams) for a while. Guys I know everyone here is pretty much anti-laser, which is cool thats your opinion and God knows I respect Spencer’s opinion, but do ya’ll think that this thing has zero validity??? This thing (premium model) has been put through the FDA (and I understand its cleared on safety and not so much on effectiveness) but it is also approved throughout international administrations (their equivielent of FDA). Now I do completely agree that the laser comb is WAY over hyped and think the results are minimal at best, but then so is Rogaine, but after numerous tests (such as the Dateline NBC story and other different trials), can we at least agree that this device will help maintain your hair rather than regrow? Also, I was curious to ask why people don’t think Ketoconazole shampoo (which does inhibit some DHT) cannot be used as another treatment for hairloss? (I hear some say it cannot penetrate into the scalp, but then how does Minoxidil penetrate into the scalp?) Food for thought..

  • Charles Maricle

    From my understanding Hairmax started delivering the new model using nine laser modules delivering nine laser spots instead of the single laser line generator in the device that was cleared by the FDA almost the same day they received their clearance. I have personally met with the FDA regarding another manufacturers product clearance. They are very specific about any product to be considered “substantially equivilent” must match the spectral patterns of the cleared device. Having done these kinds of tests, I can tell you that the new unit is different than the original one and the FDA will demand studies to prove its equivilency (as they did with the other company I was representing in this matter). Hairmax cannot make their medical claims on the new unit unless they have met this standard with the FDA.

  • Charles Maricle

    A second thought, as the FDA considers low level laser devices to be non-significant risk, in defense of Hairmax, there certainly are no safety issues that I could ever imagine. They are using all Class IIIR lasers.

  • Joe S

    Hi Destin……one study was done on Ketoconazole and is not empirical evidence by far. Generally, speaking DHT has to be blocked in the bloodstream (like Propecia does). Rogaine, is more like “caffine” to put the hairs in a “growth” phase. Real results come from blocking DHT in the blood stream or transplant…..everything else is minimal at best. I call laser, Rogaine, and Nizerol 2% non-cosmetic in their results. Yes, they might grow 15 hairs, but nobody can see them very well. Right now, DHT has to be blocked in the bloodstream, not topically. Really, the people who have had REAL success have been those who block DHT in the bloodstream. However, I can tell you that Dr. Alan Bauman is working on a compound that has finasteride and other ingredients in it that should outperform Propecia alone. It’s not completed, but I can tell you that if anyone can do it, he can. My main point is don’t “split hairs” on laser, Nizerol, and Rogaine….cosmetic results come from Propecia/bloodstream DHT blockers and Transplant as of right now.

  • Joe S

    Hello Tee Jay.

    The laser does have some effect on cells. Does that mean it can regrow hair? No. Do I still use a laser comb, No.

    I have seen the laser reduce fat cells in 2 weeks. Not the exact type of laser that Hairmax uses, but similar.

  • Smitty

    It’s true that the FDA article isn’t scientific proof of anything, but the news does have quite a number of interesting implications.

    Within the community of laser advocates, Hairmax has emerged as the king. After decades of claims about LLLT, Hairmax had declared that they had stumbled upon the exact frequency where the laser grows hair. They somehow managed to become the first and only laser company to get FDA approval, and they have been adamant about the fact that other similar products are scams. I’ve seen them dissect other laser technologies and explain how they will not work because the specifications are incorrect.

    Now here they are selling products with different laser specs. The fact that they are completely running wild with their FDA clearance and abusing it is disturbing enough. But now you also have to wonder now about all of their past claims. Are they now turning around and stating that all lasers grow hair? If so, can a five dollar laser pointer grow hair?

    This was the sole company with the bragging rights of an FDA clearance. In my opinion, they’ve just cast a huge shadow of doubt upon all of their scientific studies and claims, as well as their ethics and credibility.

    These hand held laser companies and laser helmet salons have had decades now to get it right. Hairmax has suddenly contradicted their scientific claims by pulling some sort of marketing stunt.

    Maybe we are actually spending too much time on the science, when there are certain things that are staring right at us and challenging us to use our common sense.

  • Dave Solazzo

    Wow this is all so crazy. Someone earlier mentioned brain cancer. That’s just speculation right? Is there any credible evidence that woud suggest that these combs could cause brain cancer? I worry about that with my cell phone too.

  • Firstly, all Haiirmax did was change their design from a one 26mw laser being split into roughly 8 beams to a device which uses 9 individual 5mw laser modules(each outputting about 3mw each) .
    The FDA approval was on the former, not the latter device i just mentioned.
    Basically it is the same comb with the newer design having a little more power.

    My opinion on the HAIRMAX Lasercomb and other 5mw Lasercombs is that they are very underpowered and can’t provide the neccessary 3 to 6 joules of energy per centimeter squared for the bio photo stimulation effect to occur in a reasonably short period of time(say 20 to 30minutes)

    That’s why most people using the HAIRMAX will see poor to below average results at best.

    Let’s face it, when you need to use a microscope to look for new hair, well..I think you get the picture….

    Mike
    LAZERFISH LLLT.

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"Spencer Kobren's nationally syndicated show "The Bald Truth" has a dedicated listenership that would have Rush Limbaugh pulling his hair out in envy." --Pittsburgh Tribune-Review.

 
 
 
 
 

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