Lasercomb is NOT FDA APPROVED for HAIR LOSS.
- Thread starter beaner
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Def
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This will be my final post on this because you seem to be determined to keep arguing for no reason, Bubka. You are entitled to your opinion but you don't seem to understand what the 510(k) means and the facts are:
1) Lexington submitted clinical data to the FDA initially and the FDA knocked them back because their tests and data from their initial trials were not collected accurately / scientifically enough;
2) Lexington then submitted clinical data to the FDA (a full year or so later) from randomized, controlled, placebo trials, subject to independent review and the FDA accepted this data;
3) The Hairmax laser comb, not being a drug / device used to support human life, was designated as a Class II medical device by the FDA and therefore DID NOT NEED and COULD NEVER ACHIEVE a "Pre-Market Approval" from the FDA - only a "Pre-Market Notification";
4) In view of the fact that the FDA was satisfied that the laser comb was BOTH safe AND effective in promoting hair growth, a section 510(k) certificate was issued by the FDA clearing the Hairmax laser comb as such in line with predicate devices;
5) The email Beethoven recently received from a contact at the FDA confirms that:
6) The FDA would not allow Lexington to market the Hairmax laser comb as a device that if effective in regrowing hair in males with androgenetic alopecia if it didn't; and finally
7) The Hairmax laser comb has, therefore, received a seal of approval on both counts which is a level of approval greater than any other product has achieved with the exceptions of Finasteride and Minoxidil.
All of these are FACTS and undeniable and to me are a significant indication that the Hairmax laser comb (and potentially other laser combs) are a useful adjunct to any hair loss regimen.
You can choose whether to use the Hairmax laser comb or not Bubka, but I think your constant interjecting into laser comb threads that "it is a scam" or "is bullsh*t" or "is useless" is both unhelpful and irresponsible.
Def
1) Lexington submitted clinical data to the FDA initially and the FDA knocked them back because their tests and data from their initial trials were not collected accurately / scientifically enough;
2) Lexington then submitted clinical data to the FDA (a full year or so later) from randomized, controlled, placebo trials, subject to independent review and the FDA accepted this data;
3) The Hairmax laser comb, not being a drug / device used to support human life, was designated as a Class II medical device by the FDA and therefore DID NOT NEED and COULD NEVER ACHIEVE a "Pre-Market Approval" from the FDA - only a "Pre-Market Notification";
4) In view of the fact that the FDA was satisfied that the laser comb was BOTH safe AND effective in promoting hair growth, a section 510(k) certificate was issued by the FDA clearing the Hairmax laser comb as such in line with predicate devices;
5) The email Beethoven recently received from a contact at the FDA confirms that:
6) The FDA would not allow Lexington to market the Hairmax laser comb as a device that if effective in regrowing hair in males with androgenetic alopecia if it didn't; and finally
7) The Hairmax laser comb has, therefore, received a seal of approval on both counts which is a level of approval greater than any other product has achieved with the exceptions of Finasteride and Minoxidil.
All of these are FACTS and undeniable and to me are a significant indication that the Hairmax laser comb (and potentially other laser combs) are a useful adjunct to any hair loss regimen.
You can choose whether to use the Hairmax laser comb or not Bubka, but I think your constant interjecting into laser comb threads that "it is a scam" or "is bullsh*t" or "is useless" is both unhelpful and irresponsible.
Def
beaner
Senior Member
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Wow, look what I started. I got pretty much the same response from the FDA that Beethoven received, which satisifies my curiosity in the matter. I just wanted to hear it from someone at the FDA. I guess we can conclude that while it may not be in the same class as Propecia and Rogaine, it can be an effective treatment for some. Good luck to those using it.
hair today gone tomorrow
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Beethoven said:
i attacked him? wow thats news to me....
bubka
Senior Member
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NEWSFLASH, the SlendterTone ab workout is now FDA Cleared, here is it's 510K, i saw its ad on TVRambo said:
http://www.slendertoneusa.com/
http://www.fda.gov/cdrh/pdf5/K052969.pdf
i am ordering one now!!!
doesn't that letter look familiar... where have i seen it before? hmmm
viperfish
Senior Member
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bubka said:NEWSFLASH, the SlendterTone ab workout is now FDA Cleared, here is it's 510K, i saw its ad on TVRambo said:
http://www.slendertoneusa.com/
http://www.fda.gov/cdrh/pdf5/K052969.pdf
i am ordering one now!!!
doesn't that letter look familiar... where have i seen it before? hmmm
SOOOOOOOOOOOO...................what's your point??
Headache
Member
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- 0
Then everyone's been duped.
I'm not sure who's right in this debate, but I will say this: IF the Lasercomb isn't FDA approved for hair regrowth, than the media as really been duped.
Countless news stations all around the country, and even national news, reported that the Lasercomb joins Propecia and Rogaine as the only FDA approved products to regrow hair. Their were AP stories and other print outlets as well. Not sure where they get their info, but I know it was widely reported.
As where I stand, I'm not sure. I used the comb for 3 years and it always made my scalp feel better and hair look better, but I was never sure if it helped with actual hair growth.
I'm not sure who's right in this debate, but I will say this: IF the Lasercomb isn't FDA approved for hair regrowth, than the media as really been duped.
Countless news stations all around the country, and even national news, reported that the Lasercomb joins Propecia and Rogaine as the only FDA approved products to regrow hair. Their were AP stories and other print outlets as well. Not sure where they get their info, but I know it was widely reported.
As where I stand, I'm not sure. I used the comb for 3 years and it always made my scalp feel better and hair look better, but I was never sure if it helped with actual hair growth.
bubka
Senior Member
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- 16
if you read closely, the FDA cleared the product for safety use and a type of product integrity type of certified, FDA laws forbid it for being labeled as "FDA APPROVED"
However, the marketing is very clever and misleading, which a lot of people pick up on. When they got their 510k back, hairmax equated this to what the FDA has approved propecia and rogain for, which is totally different
this 510k approval means they can legally market this product within reason of any claim they want, just like many cosmetic products can make claims regarding "reducing the signs of aging" and such
if you look on the hairmax website, not ONCE does it say "FDA APPROVED"
However, the marketing is very clever and misleading, which a lot of people pick up on. When they got their 510k back, hairmax equated this to what the FDA has approved propecia and rogain for, which is totally different
this 510k approval means they can legally market this product within reason of any claim they want, just like many cosmetic products can make claims regarding "reducing the signs of aging" and such
if you look on the hairmax website, not ONCE does it say "FDA APPROVED"
it kind of gets me mad when i think about why the fda doesnt regulate cosmetic crap like it does drugs. People lose more money on cosmetic crap and supplements then they do drugs yet the FDA does nothing. I guess that follow naturally from what our politicians do for us now as opposed to when they actually helped Americans.