HairMax LaserComb: Comb your hair up, hopefully
NOTE: You can read the follow up blog about the result of Dong's experiment here.
The developer of the HairMax LaserComb claims the comb will restore your hair and prevent hair loss by applying low-level laser therapy.
(Credit: Dong Ngo/CNET Networks)I just recently got my hands on a product that could potentially restore my thinning beauty as well as my confidence: a comb.
It's no ordinary comb. Calling it HairMax LaserComb, Lexington International, the developer of the product, claims it will restore your hair and prevent hair loss by applying low-level laser therapy--an effect similar to photosynthesis or photo-bio stimulation--to your scalp.
The therapy supposedly energizes and improves blood circulation while stimulating the growth of individual hair follicles, and, as a result, produces thicker, healthier hair and combats hair loss.
Out of the package, the LaserComb comes in a nice case that contains the comb--about the same size as a regular hair brush--plus an introduction DVD, a pair of spare comb teeth, and a manual. It seems to be a very easy product to use.
The LaserComb itself has two pairs of teeth and an array of nine laser beams in the middle. Each of these beams is the same as that of a laser pointer used for presentations. As I powered it on, the lights lit up and the comb emitted a faint beep every two seconds, which is half of the time that you are supposed to keep the comb on your head before lifting it up. The comb is designed to be used just like you use a regular comb but in much slower motion.
The HairMax LaserComb is FDA-approved and safe to be used by anyone, male and female. Lexington International claims that if used regularly--three times or more a week, 10 to 15 minutes each time--you will be able to see improvements, including thicker and more manageable hair. After a few months, you will likely notice their hair becoming fuller and denser as the hair count actually increases, according to the company.
This guy looks like he could use some heavy LaserCombing.
(Credit: Corinne Schulze/CNET Networks)Like most hair treatment therapies, there's no guarantee. Lexington International says that the results vary depending on the individual. I will personally use it for about 10 weeks to see if I am the type who's LaserComb-friendly. In the meantime, if you want to try it out yourself, you can get one for $545, which is not cheap but at least it's only a one-time charge. You can also get the HairMax LaserComb SE Edition that's more compact and has only five laser beams for $395.
Related story:
Dong Ngo is a CNET editor who covers networking and network storage, and writes about anything else he finds interesting. You can also listen to his podcast at insidecnetlabs.cnet.com. E-mail Dong. 
Don't forget the biggest scam of our time; micracle weight loss and anyrthing magic to grow you hair.
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.
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
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.
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/
- by annayuen November 23, 2009 12:52 AM PST
- 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.
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