October 15 2008, 2:33 pm PT | Posted in: Hair Products
What do you think of these Hairmax Lasercomb FDA warning letters? Does this mean the thing really doesn’t work…though a lot of it is pretty technical reading it sounds as though the thing doesn’t work…am I reading it wrong? What are your thoughts? Can you interpret it better? Here’s the link:
From what I gather, Lexington started started selling other models of their Laser Comb that were never cleared by the FDA, and yet they were inferring that they were FDA cleared. My favorite part of that letter states, “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.” So the devices differ with regard to power use and some other parameters listed in their letter, and explains why Lexington’s site says the SE model is not for sale in the US anymore.
Also, the device was cleared for use in men, and Lexington was marketing it to women when they couldn’t legally do so. That explains why Lexington changed their site information to say, “At this stage the HairMax LaserComb is only indicated for male use. A clinical study for use in females has been completed and Lexington has submitted a new 510K to the FDA for this indication.”
That letter you sent the link to shows how the FDA monitors such products and processes. Unfortunately, this letter is from May of this year (although it was just made available on the FDA site yesterday), and I’m unable to find any follow-up. I know representatives from Lexington read this site, and they can feel free to respond if they want to clear the air.
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This is interesting, considering that Lexington on their website, insists that it is the current 9 laser diode model that was cleared by the FDA (the original used one laser diode and a mirror to split the one beam into nine beams). This puts Lexington in a dilemma. Either way, they are guilty of misbranding. Here are two scenarios: 1. Either they cleared the nine laser diode model like they claim and sold the one laser diode models as being FDA cleared (if I’m not mistaken the current premium model came out in June/July of 2007 the Lasercomb was cleared in February of that year). If this is the case, the FDA got the just got some of the facts wrong, but Lexington would still be guilty of having misbranded their original device. 2. The FDA is correct with its’ accusations and Lexington in their infinite wisdom, after discontinuing their only product that had the bragging rights to being the third product recognized by the FDA to treat hair loss, has to maintain the charade in order to avoid financial ruin. Maybe Lexington got a new 510k, I would think that is the case, but then again if they did, why didn’t they get one for the SE model as well? Oh well, maybe they were too busy readying their at least two year old FDA clinical trial data to be published in a peer reviewed medical journal to handle two new 510k applications.
You know, this kind of BS is what made me start making and selling my own High Powered LASERCOMBS. HAIRMAX is flat out lying about their new design (9 lasers instead of one) being FDA approved.
It’s funny, cause when their new design came out, they made it blatantly clear on their website that the new design has 9 individual lasers. They even had a photo showing the nine lasers as well.
That photo by the way and any mention of the 9 individual lasers have been removed from their website.
So, have they returned to their old design, or are they trying to hide the fact that they are continuing to use their new design???
It really gets under my skin how they are keeping the most important people(their customers) in the dark about this whole fiasco!
Mike
LAZERFISH LLLT
I’ve been following the lasercomb since 1999 when I first started looking for potential solutions for my regressing hairline. This is par for the course for Lexington.
I once lived in south Florida. Let me tell you, Boca Raton and the surrounding area is scam central USA. Lots of businesses in that area are hand slapped by government for malpractices of one type or another. Many of your “for only 3 payments of $19.95, but if you act now…” products are based in that area. Read the fine print of the commercials.
Anyway, Lexington had always appeared to me to be a facade. Initially I was excited the lasercomb would be the real deal when I first heard about it. I could preserve my hair without having to resort to those messy chemicals Rogaine or Minoxidil, as well as stay away from medications such as Propecia. Yet, even with all my excitement, for some reason I couldn’t explain at the time, I was not able to pull the trigger to purchase a lasercomb. As time wore on, I looked at Lexington more closely only to not like what I was seeing. I noticed their before/after photos were largely cosmetic mockups. The only difference was how the hair was styled. The before pictures always had frumpy hair that hadn’t been combed or washed, and was spread out to show the scalp. Meanwhile the after pictures were always perfectly styled to show fullness. Not at all convincing as what counts is at the roots. What I really wanted to see was shaved heads with the before/after analysis performed so styling and other superficial issues wouldn’t get in the way of judgement. I requested such examples from Lexington, but they openly refused.
What really caught my attention was when Lexington filed consecutive applications for approval of the lasercomb and were denied because they didn’t conduct the before/after tests properly with their patients. That’s when it occurred to me they probably aren’t very trustworthy as a medical institution. think about it. Health is your business where you work in a lab developing a device and you don’t know how to conduct a control test? And fail multiple times for the same reason? Red flag, red flag!
Finally, what really turned me off was when I posted in their online forums, I simply wanted to ask some questions about time of delivery of the product, questions about their before/after photos, etc… because it was waaaay behind their promised delivery date. But upon clicking the submit button, I was presented with a message that more or less stated somebody at Lexington would have to review my post before it would be allowed into the forum. Many days passed and my innocent post never made it into the forum. That was the last straw, I know a fix when I see it.
While I regret to having lost a lot of hair over the past decade, I’m glad I didn’t buy into the lasercomb. Low light laser therapy may actually work - my guess is it does on a small scale for limited cases, but even so, I don’t trust it coming from Lexington.
I get the feeling the only way to a full head of hair in the near future will be this ‘hair induction’ system I see written about.
I should amend my previous post to say by, “promised delivery date”, I meant the date Lexington promised the lasercomb would be FDA approved to regrow hair. Lexington promised that day would come for nearly a decade with nothing but foulup after foulup to show for it in the application process.
I also tried posting a comment on their website forums a few years ago questioning the effectiveness of this laser. Like Matt, I also received a message saying that it would have to be reviewed first, but it never appeared. It certainly explained why there was only positive comment on their forum!