Question about HairMax Laser and FDA approval

[kingel]

I've been using Minoxidil on and off for a few years to stop a thinning hairline/baldspot. After intense irritation of the scalp I stopped using it, and suddenly my bald spot multiplied. I guess it had been working....

I was watching the Big Idea show on CNBC the other day about hair loss and it got me kind of pumped up again to try and stop my hair loss. The Laser Hair Comp think kind of intrigued me as they said it was now only the 3rd thing approved by FDA to regrow hair.

I started researching it a little and didn't see much about the FDA approval other than a blip on the Hair Max sight saying a statement was coming soon, but the FDA had approved it to regrow hair.

I've seen posts here and there with some for the laser combs and against, but I find it strange that there hasn't been more excitement on any forums that I visited about a new FDA approved treatment, so that makes me wonder if I am missing something.

If it is the third product out of thousands to be given a high level of legitimitcy from the Fed, why not more talk about it? This should be a bid deal, I would think. Any thoughts?

Finally, what I'm nervous about is- is this thing going to give me brain cancer or something 30 years from now!!!? Even FDA Approved stuff can come back to bite people years down the road. Anyone know what exactly would I be shooting into my brain? If Cell phones might cause tumor's, what about lasers?

Sorry if I'm an idiot, but at first I was excited about the laser comb, but the lack of talk out there, makes me wonder.....

 

[Private Ryan]

http://www.hairmaxforum.com/forum/showt ... #post11522

BOCA RATON, FL, January, 2007 – Lexington International LLC is proud to announce the landmark achievement of US Food & Drug Administration (FDA) clearance for their medical laser device, the HairMax LaserComb. Through years of extensive research and clinical studies in the science of hair growth, Lexington has developed an affordable and convenient, hand-held laser device, clinically proven to promote hair growth in males with androgenetic alopecia (Norwood II A to V with Fitzpatrick skin types I to IV).

For the FDA submission, Lexington conducted an extensive clinical study in four different locations around The United States. The study concluded that 93% of the participants (ages 30-60) using the HairMax LaserComb had an increase in the number of terminal (thick) hairs. The average number of terminal hairs per square centimeter increased by 19 hairs/cm² over a six-month period. During the study, there were not any reports of serious adverse events. The number and types of adverse events were similar in both the active and placebo groups.

Lexington’s clinical study demonstrating the efficacy of the HairMax LaserComb in females is concluding and we will be submitting the data to the FDA shortly.

David Michaels, Managing Director, shares his thoughts on this momentous announcement, “I believe the results of this study are far more significant than any other product on the market today. We are very excited about having reached a major milestone in hair care and science. Laser hair therapy is the talk of the hair restoration industry and with our FDA clearance behind us, we are now soundly positioned to dominate this emerging Laser treatment segment.â€￾

It is estimated that 55 million men are suffering from hair loss in the United States alone. Until recently, the FDA has only approved two other products as solutions to combat hair loss. The clearance of the HairMax LaserComb offers an exciting new modality for the stimulation of hair growth in males. Compliance is a key factor in the efficacy of any hair growth treatment. Fortunately, The HairMax LaserComb is very easy to use in the comfort and convenience of your own home, treatments last 10 to 15 minutes three times per week. The HairMax LaserComb is also the only drug-free option available thus allowing many who were previously unable or weary of drug based solutions new found hope in their battle against hair loss.

Dr. Matt Leavitt, Chief Medical Advisor to Lexington, expresses his enthusiasm on news of the clearance, “The HairMax LaserComb is a method of treatment that can be of great help to men of all ages suffering from hair loss. I am impressed with the protocol and results from the clinical trials that Lexington has conducted. With the FDA clearing the HairMax LaserComb as a medical device, it offers an attractive option for hair growth for medical practitioners. We can now deliver a new modality to our patients and achieve strong user satisfactionâ€￾.

Randy Veliky, Lexington COO, comments, “The HairMax LaserComb will revolutionize the hair growth industry, but we are not stopping there. Lexington is dedicated to continuing research into laser technology. We will be expanding our offering of laser hair growth solutions to include freestanding clinical units, affordable laser panel arrays for the home market and broadening the features of our current products.â€￾

For over 20 years, the directors of Lexington have been at the forefront of laser hair growth research. Born from this passion for innovation, The HairMax LaserComb uses a patented technology to part the hair allowing the focused laser energy to reach the scalp. The laser is most effective when it has an unobstructed path directly to the hair follicle. Extensive research has also allowed Lexington to determine the optimal wavelength and energy level to deliver maximum results. Lexington’s continued dedication to consistent innovation ensures that users are always receiving the latest in Laser hair technology.

About Lexington International, LLC
Based in Boca Raton, Florida Lexington International manufactures and distributes the HairMax LaserComb® (http://www.hairmax.com) to more than 80 countries and has provided new hope and satisfaction to tens of thousands of customers since 2001. The HairMax LaserComb is based on 20 years of international research and studies on the effects of Low Level Laser use. Both the press and users alike have universally taken to the HairMax LaserComb. Coverage has included Dateline NBC, TIME Magazine, as one of their “Inventions of the Yearâ€￾, as well as the November 2004 issue of Good Housekeeping Magazine.

Lexington is a proud member of “Team Floridaâ€￾ and has participated in high-level, overseas trade missions with Governor Jeb Bush. Additionally, the company was awarded by the U.S. Department of Commerce for “Commercial and Export Achievementâ€￾.

 

[kingel]

Good news. Now, am I going to have a tumor 25 years from now if I use it? Is there a danger to shooting lasers into your brain, or maybe it doesn't penetrate the skull...

 

[Private Ryan]

do you ever bother to do some research on product you interested in?

 

[kingel]

Absolutely, I do. That's what I'm doing now. Everything I have read says no side effects, but I haven't seen anything even mentioned about long term exposure to these rays. Sorry if my questions are dumb, but I thought someone might have some insight.

 

[Guest]

is there any evidence that these things work in actual FDA studies? just because the FDA clears them to sell it as a hair aid doesn't mean it is effective at stemming hair loss.

 

[powersam]

Jayman - well the FDA clearing it to be sold as such, means that the FDA does indeed believe it promotes hair growth.

 

[tembo]

I wish you hadn't left the paragraph with Jeb Bush in there.

After Halliburton, I wouldn't trust any company with such close high level political connections.

 

[Guest]

Jayman - well the FDA clearing it to be sold as such, means that the FDA does indeed believe it promotes hair growth.

i don't think so. there's a difference between an fda approved medication for hair loss and the fda product approving a product to be sold intended for hair loss. propecia and minoxidil are the only two fda approved products for hair loss. sh*t like procede still has to go before the fda to make sure it's safe, etc. right?

 

[Fallout Boy]

Racist Laser Comb

Well according to HairMax's website the FDA has approved it to promote hair growth which would make it the 3rd product approved by the FDA for hairloss. The others ofcourse are Finasteride and Minoxidil. If thats true than holy sh*t thats pretty big news right? Another product to the list that FDA claims actually works.

But the weird thing is that it only works on Norwood 2's and doesn't work on black people....if i'm understanding this correctly.

It say's it works on Fitzpatrick Skin Types I - IV

Fitzpatrick Skin Type and Description

I extremely fair skin - always burns, never tans
II fair skin - always burns, sometimes tans
III medium skin - sometimes burns, always tans
IV olive skin - rarely burns, always tans
V moderately pigmented brown skin - never burns, always tans
VI markedly pigmented black skin - never burns, always tans

 

[Guest]

It's funny how they call it the Fitzpatrick scale. Is that because Fitzpatrick is an Irish name and most Irish people are a type I with extremely fair skin?

I guess I'm a type II on that scale because I almost always burn but I get a good tan afterward.

 

[kingel]

To answer my safety question, Hair Max emailed me and said that the lasers only penetrate the scalp and not the skull. Intensity and wavelength are designed as such and over 20 years of use and no adverse effects have been recorded.

Also specifically stated to me that they are now the only product other than minoxidil and Propecia to be FDA approved and those three are the only products that can claim this. Said FDA cleared HairMax to announce this, and FDA would soon be releasing results of studies, investigations, etc

 

[grabber]

Take a look at their web site, they have what they call micro picture of the hair .... It looks good to me.

 

[DoctorHouse]

Using Lasers is very effective. I watched the pop-up movie version of Stars Wars and learned Chewbacca grew most of his hair from using Propecia, Rogaine and most importantly the Laser saber comb by Hamilmax. I heard it comes in a variety of colors. I just bought the green one and it produces an out of this galaxy great force on my hair follicles. My hairline was like Yoda's but now its as thick as a Wookie. :hairy:

 

[Fallout Boy]

How come more people arent talking about this??

 

[HLTguest]

Take a look at their web site, they have what they call micro picture of the hair .... It looks good to me.

Jayman gave a link on another thread that debunked those photos I think. Actually some hair counts went down after using the lasercomb.

 

[Cassin]

It say's it works on Fitzpatrick Skin Types I - IV

Fitzpatrick Skin Type and Description

I extremely fair skin - always burns, never tans
II fair skin - always burns, sometimes tans
III medium skin - sometimes burns, always tans
IV olive skin - rarely burns, always tans
V moderately pigmented brown skin - never burns, always tans
VI markedly pigmented black skin - never burns, always tans

I remember when Rogaine first came out they said the same thing. I wonder why it went quite?

 

[Cassin]

How come more people arent talking about this??

Its expensive and we have been hearing about it forever. Used to be tons of posts about it.

 

[Fallout Boy]

yea i know that but if it got FDA approval doesn't that take away a lot of your doubt's if the laser comb works or not????

 

[Cassin]

yea i know that but if it got FDA approval doesn't that take away a lot of your doubt's if the laser comb works or not????

Sure, but "IF"

If If If If

We keep hearing that about them.

They built up so much momentum and talk a few years ago and sort of blew out their flame by delays and excuses.

I hope it works, I would buy one. But I have serious doubts now.