Comments on: HairMax LaserComb: Comb your hair up, hopefully

Comb your hair up with LaserComb.

[carguy622]

Oh please! Years from now these types of devices will be at a local Ripley's Believe-it-or-Not just like all those crazy combs that came out when electricity was becoming popular. Back then it was: "Electricity is there anything it can't do", not it's "Lasers is there anything they can't do". Yes, grow hair!

[uruwa64]

It doesn't work don't get fooled. Let the manufacturer show before and after picture, then we can judge.
Don't forget the biggest scam of our time; micracle weight loss and anyrthing magic to grow you hair.

[danskpeber]

"The HairMax LaserComb is FDA-approved and safe to be used by anyone, male and female."

Be sure you realize the difference between FDA approval of a device (as is the case here) and FDA approval of a product. The product, usually a medicine, goes through rigorous testing and must show both safety and efficacy while FDA device approval only means the product is safe to use, it doesn't look at whether or not it is effective. Companies commonly use this little trick to imply that the FDA has stated the device has been tested and actually works (since most people don't realize the difference). Usually if something looks like snake oil it in fact is.

[LexingtonInt]

We?d like to thank you for taking the time to acknowledge the HairMax LaserComb on your Web site. We take this opportunity to respond to some of your comments and attempt to put to rest much of the ongoing debate over the HairMax LaserComb on your site.

In January of 2007, the HairMax LaserComb was Cleared by the FDA for the ?Promotion of Hair Growth? in males with certain classes of Androgenetic Alopecia. This Clearance was based, not solely on a safety, but also on solid clinical data from our multi-centered double blind sham controlled study which followed all Good Clinical Practices.

For your readers reference, there are two processes for medical device approvals from the FDA, one being PMA (Pre-Market Approval) and the other is a 510K. Since our laser is considered a NSR (Non Significant Risk) device as defined by international laser safety standards, we appealed to the FDA to submit a 510K based on the safety of predicate devices.

Our extensive clinical study, device labeling, GMP (Good Manufacturing Practices) and ISO (Quality) accreditation was the basis of receiving the FDA 510k Clearance.

The study took place at 5 sites throughout the United States. We are currently drafting a medical review of the study to be submitted to a peer-reviewed journal. We have every intention of publishing the study and making the full results available for public scrutiny.

Our statistical data, along with macro analyses of trial participants? before and after images were proven to be medically significant. Our clinical protocol was IRB approved, followed GCP (Good Clinical Practices) and we utilized clinical trial monitors to verify all source data and case report forms. Please understand that we had to prove to the FDA, under the same statistical scrutiny as both Propecia and Minoxidil, that the HairMax was effective in increasing ?Hair Counts? in men with Androgenetic Alopecia.
In addition, we have just completed a clinical study for female Androgenetic Alopecia and have filed a new FDA 510K submission for females. We are cautiously optimistic that it will receive Clearance for females suffering from hair loss.

As for statements concerning the difference between FDA approval and FDA clearance, here is the rule of thumb for submissions cleared by the FDA: In general, Drugs are ?Approved? for sale, and Medical Devices are ?Cleared? for an ?Indication of Use?.

Finally, some blog posters comments of the HairMax always seems to point to an alleged lack of clinical data and a clear mechanism of action.

Similar to Rogaine, how the HairMax LaserComb works is debatable and evolving. It is our hypothesis that the HairMax LaserComb, in some way, stimulates the dermal papilla leading to increased cell proliferation of the hair matrix. We believe this process causes increased production of the hair fiber. Supporting this hypothesis are user reports of faster growing hair.

We further hypothesize that the HairMax is an anagen inductor, and support this hypothesis by user reports of increased shedding at the onset of treatment. To us, this indicates an increase in telogen fallout leading to healthier anagen growth.

A few prominent hair researchers suggest that the HairMax LaserComb may also have some effect on cell apoptosis, but we will not comment further as we know it will spark debate and we do not have any scientific premise to support this theory, yet.

We are about to conduct further research with histologic biopsies to document some of the changes which occur after HairMax LaserComb usage.

Please understand that when we went public with the fact that we were proceeding with clinical trials, naysayers complained that it was just a farce for us to attempt to increase business. Now that we have proven, through our FDA clearance, that clinical trials were conducted, some people still continue to be skeptics?The real issue seems to be that people are not willing to move away from the status quo. Rogaine and Propecia are approved; we are Cleared; all three of us have been proven as effective treatments for Androgenetic Alopecia.

We don?t guarantee that everyone will see results. From our extensive anecdotal experience spanning over 20 years, we have seen that 45% of users see benefits quickly, 45% of users see benefits over time, and 10% of people will see little results. Keep in mind, compliance is a major factor in the realization of benefits. In reality, treatments for any condition are never a sure bet, and we do not contend that our product is a miracle for hair loss sufferers. It does, however, offer well founded hope and quantifiable results, and that?s what we?re about.

To conclude, we have been collaborating with leading hair researchers and clinics across the world. What we?ve found is that the experts who actively use the HairMax LaserComb accept its efficacy; those who do not remain skeptical.

This seems to be the same issue we encounter with non-users of the HairMax LaserComb who are quick to complain that it is ineffective, but are unwilling to give it a chance to work. The HairMax LaserComb has been on the market since 2001, and one of the key factors in marketing a medical device is user experiences. We believe the HairMax LaserComb has one of the highest levels of customer satisfaction of any hair treatments. In addition to positive changes in hair growth, the quality, condition, tensile strength and manageability of the hair is enhanced. We offer a money back guarantee to our direct customers; if the HairMax LaserComb was not an efficacious treatment we would have been in the archives of a ?hair loss snake oil? schemes by now. Instead, we have achieved FDA accreditation and gained acceptance from hair experts and have satisfied users worldwide.
We hope that this clears up any misunderstandings your readers may have about our medical device.

Sincerely,

Lexington International LLC

[annayuen]

Appreciate Lexington's comment. But I am still trying to figure out whether their laser comb is good for men only, or both men and women.
http://1hairregrowth.blogspot.com

[alawaiblowfish]

OOOH Smack! They done told all of you!

[ServedUp]

In theory I can see how it would promote hair growth. They've been using laser therapy for years in beauty salons for those who could afford it (like Movie Stars). The misconception of this device though is that it will instantly grow hair in people who've already lost it, but in actuality its used to stop hairloss in those individuals who still have hair, but who are starting to see the initial onset of Male/Female pattern baldness (e.g. thinning of the hair).

I'm not a bald person, but I understand the chemistry of hairloss and the theories behind the laser comb seem to suit the general idea of stopping hairloss which are; promoting blood flow and reducing the chemical component of DHT in the scalp which causes the hairloss in the first place.

Looking ahead lets just say from this point forward Generation Y shouldn't have to worry about going bald with so many proven remedies out there like saw palmetto, rogaine, propecia and the laser comb.

[htn1001]

Proof HairMax LaserComb is a scam:

http://www.youtube.com/watch?v=YqveOrNqMnI

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

http://www.thebaldtruth.com/news/fda-warning-letter-hairmax-lasercomb/

[annayuen]

Laser comb is something debatable. I've heard some users saying 'good' while some others saying 'useless'. Wonder what will determine who is laser-comb-friendly. But I do see my sister who once lost 90% of her hair used low laser therapy to get her hair back.
http://1hairregrowth.blogspot.com