FDA approval for lasercomb finally?????

[lithebod]

I decided to visit the Hairmax website to see what silly delaying tactic they would be using about their "imminent" FDA approval and to my disbelief they are actually saying they have got approval from th FDA for hair growth!!! - is there anyway to validate this claim - I went to the FDA site and couldnt find it in its list of approved products - this is pretty big news if its true



FDA Clears the HairMax LaserComb for the Promotion of Hair Growth

--------------------------------------------------------------------------------

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 investigating the efficacy of the HairMax LaserComb in females is concluding and we will be submitting the data to the FDA shortly.

 

[HLTguest]

This has to be BS. I wish it wasn't. But I'm almost positive it is. LaserComb seems like the ultimate scam.

 

[Guest]

well a Doctor did look at the pics for it on a dateline special and say that it gave one guy who used it good results. i used to think it was a total scam as well but maybe it has some merit.

 

[HLTguest]

Here are some pics. They must be too good to be true. I just can't believe them.

http://www.lasercomb.net/beforeafter.htm

 

[Guest]

actually i now agree with you hltguest.

here's a good link to read:

http://www.baldingblog.com/2006/08/03/a ... aser-comb/

 

[HLTguest]

Thanks for the link. Although, upon watching the dateline footage again, I am even more confused. The doctor does indeed say he is impressed. I don't see much improvement, maybe a tiny bit. Its hard to tell with his hair cut. But the doctor said he saw new follicles, and he was on dateline, so I don't know what to think.

Also, I take back what I said in the other thread about propecia results being pathetic. The drug is designed for maintenance, not regrowth really, so the results aren't bad at all. The older man (also used rogaine) didn't lose hair any hair at least (Doctor said he actually had slight gain, although I didn't see any difference). And the younger guy had good regrowth actually on propecia alone.

But back to this lasercomb, I am very curious about this FDA business. Can anyone debunk this possible myth of FDA approval?

 

[Guest]

Thanks for the link. Although, upon watching the dateline footage again, I am even more confused. The doctor does indeed say he is impressed. I don't see much improvement, maybe a tiny bit. Its hard to tell with his hair cut. But the doctor said he saw new follicles, and he was on dateline, so I don't know what to think.

Also, I take back what I said in the other thread about propecia results being pathetic. The drug is designed for maintenance, not regrowth really, so the results aren't bad at all. The older man (also used rogaine) didn't lose hair any hair at least (Doctor said he actually had slight gain, although I didn't see any difference). And the younger guy had good regrowth actually on propecia alone.

But back to this lasercomb, I am very curious about this FDA business. Can anyone debunk this possible myth of FDA approval?

FDA approval doesn't mean that it's approved as a hair loss treatment like Propecia and Rogaine. Those went through 3 phases of trials where they spent billions of dollars. Just because they say it's FDA approved doesn't mean that they've proven to the FDA that it grows hair. Anything sold to consumers like this or vitamins or anything has to be proven safe. It's different as far as I know.

As for the dateline Doctor, I've realized that he doesn't know what he's talking about and that was subjective as you know. Rassman counted the hairs and he is an expert in densitometry considering he holds the patent, so I trust him over the LaserComb people.

 

[haunted-ballroom]

Thanks for the link. Although, upon watching the dateline footage again, I am even more confused. The doctor does indeed say he is impressed. I don't see much improvement, maybe a tiny bit. Its hard to tell with his hair cut. But the doctor said he saw new follicles, and he was on dateline, so I don't know what to think.

Also, I take back what I said in the other thread about propecia results being pathetic. The drug is designed for maintenance, not regrowth really, so the results aren't bad at all. The older man (also used rogaine) didn't lose hair any hair at least (Doctor said he actually had slight gain, although I didn't see any difference). And the younger guy had good regrowth actually on propecia alone.

But back to this lasercomb, I am very curious about this FDA business. Can anyone debunk this possible myth of FDA approval?

FDA approval doesn't mean that it's approved as a hair loss treatment like Propecia and Rogaine. Those went through 3 phases of trials where they spent billions of dollars. Just because they say it's FDA approved doesn't mean that they've proven to the FDA that it grows hair. Anything sold to consumers like this or vitamins or anything has to be proven safe. It's different as far as I know.

As for the dateline Doctor, I've realized that he doesn't know what he's talking about and that was subjective as you know. Rassman counted the hairs and he is an expert in densitometry considering he holds the patent, so I trust him over the LaserComb people.

Are you sure about that? If that were the case, wouldnt there be hundreds of FDA approved hairloss treatments? Like all those shitty herbal remedies and things...

 

[Guest]

Thanks for the link. Although, upon watching the dateline footage again, I am even more confused. The doctor does indeed say he is impressed. I don't see much improvement, maybe a tiny bit. Its hard to tell with his hair cut. But the doctor said he saw new follicles, and he was on dateline, so I don't know what to think.

Also, I take back what I said in the other thread about propecia results being pathetic. The drug is designed for maintenance, not regrowth really, so the results aren't bad at all. The older man (also used rogaine) didn't lose hair any hair at least (Doctor said he actually had slight gain, although I didn't see any difference). And the younger guy had good regrowth actually on propecia alone.

But back to this lasercomb, I am very curious about this FDA business. Can anyone debunk this possible myth of FDA approval?

FDA approval doesn't mean that it's approved as a hair loss treatment like Propecia and Rogaine. Those went through 3 phases of trials where they spent billions of dollars. Just because they say it's FDA approved doesn't mean that they've proven to the FDA that it grows hair. Anything sold to consumers like this or vitamins or anything has to be proven safe. It's different as far as I know.

As for the dateline Doctor, I've realized that he doesn't know what he's talking about and that was subjective as you know. Rassman counted the hairs and he is an expert in densitometry considering he holds the patent, so I trust him over the LaserComb people.

Are you sure about that? If that were the case, wouldnt there be hundreds of FDA approved hairloss treatments? Like all those shitty herbal remedies and things...

it means the fda has said that it's safe i think. not that the fda has endorsed their claims.

 

[weezerboi18]

Does anyone have an idea how much a laser comb cost?

 

[cmoneyt8ker]

Does anyone have an idea how much a laser comb cost?

posts like this drive me up the wall...you are on the internet. You can find out in less time than it took you to write that post.

 

[lithebod]

this isnt anything to do with the dateline feature - if you read the press release from Hairmax that I attached in my original post they are actually claiming they have had approval from the FDA FOR HAIR REGROWTH - they have never claimed this before which is what stunned me - before they used to say its FDA approved for the safety of the laser but now they clearly seem to be claiming that they have approval - Ive always been very skeptical about the lasercomb hence I wondered if anyone knew of a resource that this could be verified against.

 

[AussieExperiment]

Pictures look like a scam

Here are some pics. They must be too good to be true. I just can't believe them.

http://www.lasercomb.net/beforeafter.htm

Some of these images are typical pictures used by scams.

Person 1
In the After picture the guy has the most obvious combover.

Person 2
In the before picture the guy has wet hair and in the after picture he has dry hair.

Person 3
Minimal Growth - probably the best photo they have posted

Person 4
Maybe I am missing something but the before photo looks better. She seems to have lost hair in the after photo around the crown area. Plus, in the before picture she has highlights through her hair and in the second image she doesn't.

Person 5
Before picture looks better. She seems to have lost hair in the after photo around the crown area.

Person 6
Very, very minimal difference

Person 7
Gained some hair around the front but lost some hair around the crown

Person 8
Very, very minimal improvement around the front

NEED I GO ON. Is it just me or are these photos pathetic. If this is the best the lasercomb can do than I will save my $800.

 

[tchehov]

I agree. Some of the before pictures ARE better. And the others show minimal regrowth at best - to me they just look like they have brushed their hair differently for the after shot.

Might as well just stick your head inside your CD player. I wonder if a thousand dollar CD player grows more hair than a hundred dollar CD player.

 

[lithebod]

people are still missing the point of this thread - hairmax are claiming that the FDA have APPROVED the lasercomb for promoting hair regrowth - that is major - ive emailed th FDA to see if they can confirm it

 

[tchehov]

So will the lasercomb get its own forum here at gourmetstylewellness.com if the FDA have approved it? I think that would be a much more convincing reference.

 

[Guest]

guys to get approval by the FDA as a hair regrowth agent, it has to go through phase III trials, which cause hundreds of millions of dollars. rogaine and propecia both went through these. i seriously doubt that lasercomb has that kind of cash.

 

[HLTguest]

Might as well just stick your head inside your CD player. I wonder if a thousand dollar CD player grows more hair than a hundred dollar CD player.

I love the bluntness on this forum. It really puts things in perspective.

 

[lithebod]

IT IS TRUE!!! I emailed the FDA last night and they pointed me to the following link with this response - wow so all this time I thought the Hairmax guys were bs'ing they were doing clinical trials - check this out:

In response to your inquiry below, we have recently granted FDA marketing clearance to the HairMax Laser Comb. Here is the link to it.

http://www.accessdata.fda.gov/scripts/c ... m?ID=20683

SO what does marketing clearance actually mean? i.e. based on the clinical data submitted they can market the device as promoting hair growth - is this the same as minoxidil and propecia - if anyone has any knowledge of the FDA process input is welcomed

 

[grabber]

Take a look at this. PDF format.

http://www.fda.gov/cdrh/pdf6/K060305.pdf

Quote :
A multicenter, randomized, placebo-controlled trial was conducted at four sites in the United States. Subjects received either the LaserComb or a sham device. Subjects were instructed to use de device three times per week on nonconcurring days for a total of 26 Weeks. Subjects in the lasercomb treatment group had significantly greater increases in mean terminal hair density than subjects in the placebo group. Subjects in the lasercomb group also had significantly better subjective assessments of overall hair regrowth than subjects in the placebo group. No subject experienced a serious adverse event and the adverse event profiles were similar between the two treatment groups. In all instances, the LaserComb functionned as intended and the hair regrowth observed was as expected

end of quote.