Lasercomb is NOT FDA APPROVED for HAIR LOSS.

[beaner]

I have no interest in using it even if it was, but to settle the arguments regarding if it is or isn't I discovered the answer by actually taking the time to research the matter...oh no, why didn't anyone think of doing that?

Anyway it is NOT FDA approved for hairloss, but merely FDA approved to be sold in the U.S.

The manufacturer had to submit a 510(k) application (for medical devices) to the FDA. Below is the application and the response from the FDA.

http://64.233.169.104/search?q=cache:Au ... cd=1&gl=us

Pasted here is the FDA procedure in regard to the 510(k) submissions clearly indicating that they are NOT giving their approval to the devices in question, but only approving their sale in the U.S.

STEP 2: The FDA reviews your 510(k) application

Once you have submitted your 510(k) to the FDA, they legally have 90 days to review it. During that process, they may ask you for additional information at which time the "clock" is stopped and then resumed upon the FDA's receipt of your answer to their questions. If approved, the FDA will mail you a letter, with an assigned 510(k) number, that says they "have determined that your device is substantially equivalent to legally marketed predicate devices...and you may therefore market the device subject to general controls provisions of the (Food, Drug and Cosmetics) Act" Essentially, when they send you the letter, they are not approving your device, they are saying that your device is much the same as other devices (predicates) already approved by the FDA. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is approved for sale in the US.

This "approval" means nothing. The FDA does not support any claims that the Hairmax Lasercomb grows hair.

 

[bubka]

just read this "interview" from the president of the magic laser wand:

http://www.hairlosshelp.com/hair_loss_n ... #interview

my favourite part:

How many people were in your study you submitted to the FDA?

A number deemed to be statically significant.

:roll:

like i have said 1005 times now on this forum, it is approved as a cosmetic devices, which allows it to be marketed with just about any type of language like wrinkle creams and those penis creams

i will admit, they are very cleaver with their language, like saying it is FDA "cleared" however, they cannot say "FDA approved" for _________ which they do not claim, as idiots here do say as well

http://www.lasercomb.net/default.aspx

from the FDA website about cosmetics:

http://www.cfsan.fda.gov/~dms/cos-lab4.html

Is it permitted to label cosmetics "FDA Approved"?

No. As part of the prohibition against false or misleading information, no cosmetic may be labeled or advertised with statements suggesting that FDA has approved the product. This applies even if the establishment is registered or the product is on file with FDA's Voluntary Cosmetic Registration Program (VCRP) (see 21 CFR 710.8 and 720.9, which prohibit the use of participation in the VCRP to suggest official approval). False or misleading statements on labeling make a cosmetic misbranded [FD&C Act, sec. 602; 21 U.S.C. 362].

 

[beaner]

I never paid much attention to the Lasercomb, but seeing threads all over the forums with all these people excited about the "approval" got me wondering, so I did a Google search and within 5 minutes found that it really isn't approved like everyone thinks.

I saw in your other post that you had posted this info before, which I missed. I think this needs to be made a sticky. Cassin?

 

[bubka]

and it's the same people too, which is a shame, i guess i would defend my purchase too and want to "believe" in it if i paid $500 for a magic wand

check it out, i posted exactly what you did, though the actual image / pdf letter

http://www.gourmetstylewellness.com/discussions ... tic#343050

 

[Def]

It does mention in there that it is indicated to promote hair growth in men with adrogenetic alopecia. It also provides a precis of the performance data from milti-centre, randomized, placebo controlled tests... Statistically significant increases in terminal hair density. I would say that's approving it for sale as a medical device that promotes regrowth.

What additional releases / approvals have the FDA issued in relation to finasteride / minoxidil?

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

 

[bubka]

It does mention in there that it is indicated to promote hair growth in men with adrogenetic alopecia. It also provides a precis of the performance data from milti-centre, randomized, placebo controlled tests... Statistically significant increases in terminal hair density. I would say that's approving it for sale as a medical device that promotes regrowth.

What additional releases / approvals have the FDA issued in relation to finasteride / minoxidil?

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

the "trial" was their own in house, and had i think a number of 42 people, i mean, there are high school experiments that have a larger population, plus some of the findings were not even significant

when you say "it does mention" you need to see what is the hairmax BS, and what is the actual FDA, hairmax doe not even mention the specifics of their "study" for a reason

finasteride and minoxidil have had numerous studies, all with the same, conclusive, significant, and pier reviewed results, this is not something you can scrutinize

seriously, i know it's tough to part with your $500 you were swindled on this product

NOTICE how you guys all say is is "FDA approved" ???? try to find "FDA approved" on their website?? you CANT, because it is not, they say FDA "cleared" or some BS, like we said, it is cleared for safety, and can be
marketed as a cosmetic device

here is some finasteride FDA approval information

http://www.enotalone.com/article/5711.html

http://www.fda.gov/cder/foi/label/2001/20788s003lbl.pdf

 

[Def]

I don't and never have owned a Lasercomb of any kind. I'm just interested in understanding why there is so much skepticism about a product that has (more than any product other than finasteride or minoxidil - and possibly Tricomin) gone through the rigors of the FDA.

It clearly states in the 510(k) certificate that FDA "approved", "authorised", "sanctioned" (or whatever other word you want to use) indicated use for the Lasercomb is "to promote hair growth in males with androgenetic alopecia". The FDA does not allow entities to market products with misleading labelling and regulates such marketing rigorously. The 510(k) is a pre-market notification stating that Hairmax can advertise as such... I'm not sure about the other steps towards FINAL approval.

You are no doubt right about the number of studies conducted, however, everything else that you say is mere speculation and relies on the semantics of how things are presented on the Hairmax website etc. You could be 100% right but I'd like to find out for sure (some how) because in my opinion what you write holds less weight than the piece of paper I can read from the FDA...

The cost of the thing is a different matter altogether - $500 probably is way too much since other people on the net seem to be able to build them (even at home) for as little as $50. You just get some (and perhaps only some) peace of mind as to quality control when you get it from Lexington.

 

[Def]

I just thought I'd spend 5 minutes actually looking to resolve this issue and here is some useful information from the FDA site. The 510(k) pre-market notification is a lower threshold and easier hurdle to meet than pre-market APPROVAL it seems.

http://www.fda.gov/cdrh/consumer/product.html#3

The information will all be on the FDA site as it's quite comprehensive but I can't be bothered looking.

Someone with some time should be able to put this question to bed by determining what FDA pre-market NOTIFICATION actually means.

 

[beaner]

Essentially, when they send you the letter, they are not approving your device, they are saying that your device is much the same as other devices (predicates) already approved by the FDA. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is approved for sale in the US

I thought the above statement pretty much said it all. I could be wrong and if someone understands the process better, please pipe up. I'm not saying the thing doesn't work, I hope it does for all those that forked the $$ over for it, but it just doesn't seem that this "approval" is the same as the approval given to minoxidil and propecia.

 

[Ouroboros]

I get what you guys are saying; its just, as I said in the otherpost; from what I know photobiostimulation is safe and works (from its other medical uses)...it just plain makes sense to me, valid approval or not.

 

[viperfish]

No, your wrong it is FDA approved for regrowth.

 

[beaner]

No, your wrong it is FDA approved for regrowth.

What make you say that, seeing the info I found points to the contrary? I'm not arguing, I'm just trying to understand the process by which this was approved for hair growth. It sounds like you have the answer.

 

[viperfish]

Included in the 501 (k), which was left out by the other poster (only part was displayed) on here is this statement:


"The clinical data demonstrates that the lasercomb is effective in promoting regrowth and does not present any saftey issues. Therefore, the lasercomb satisfies FDA's substantial equivalance criteria. Thus, the FDA should clear the device via the 501 (k) notice containing the clinical data."

It says in plain english that it was approved through the use of the 501 (k) notice for REGROWTH.

 

[beaner]

What I posted twice, says in plain English that this does not mean the FDA has given approval to said products, but are approving them to be sold in the U.S. so this information is contradictory.

Anyway, I just emailed the FDA. Hopefully a representative from their organization can shed light on this.

 

[klink]

I know you want to try it beansie old chum, doooo itttt!

I told my wife about this device and she laughed at me like I had just taken a crap on the floor.

 

[bubka]

No, your wrong it is FDA approved for regrowth.

NO IT IS NOT, jesus christ you guys cant even read? WHY doesn't the official website say so then?

just because you got duped into paying $500 for a laser pointer with combs, does not mean you have to support your purchase

Included in the 501 (k), which was left out by the other poster (only part was displayed) on here is this statement:


"The clinical data demonstrates that the lasercomb is effective in promoting regrowth and does not present any saftey issues. Therefore, the lasercomb satisfies FDA's substantial equivalance criteria. Thus, the FDA should clear the device via the 501 (k) notice containing the clinical data."

It says in plain english that it was approved through the use of the 501 (k) notice for REGROWTH.

thats what the hairmax laser wand people say, not the FDA... can you not see the difference, this is approved as a safe cosmetic device, and it can be marketed as so as it falls under that category...

 

[beaner]

I know you want to try it beansie old chum, doooo itttt!

I told my wife about this device and she laughed at me like I had just taken a crap on the floor.

I would try it if I heard of enough people say it was helping. I wouldn't pay for a Hairmax, though. I would probably get the Amazing Laser Brush for 120 bucks or make my own, as it seems pretty easy to do. But, I'm afraid, this thing is all hype based on the acronym, FDA, that suddenly found it's way into the product description. I hope they answer my email so this thing can be put to rest on either note.

 

[Def]

On my quick review of the FDA website just now, the difference between a "Pre-Market Approval" and a "Pre-Market Notification" is that only certain kinds of devices (ie Class III) need to go through Pre-Market Approval. Class III devices are those that support or sustain human life and therefore need more stringent testing.

A lower threshold is used for Class I and Class II devices - the Pre-Market Notification.

So from what I have read on the FDA website, a Pre-Market notification is the official sanctioning from the FDA that a device:

(a) does what it is advertised to do; and
(b) is safe for use by the public.

With specific reference to the Hairmax:

(a) it is indicated and may be advertised for the promotion of hair regrowth in males with androgenetic alopecia (because it has the ability to do this); and
(b) is safe to use with no material adverse effects.

I am not sure where Bubka is coming from with his statements that it has been approved only as a "safe, cosmetic" device.

From what I can tell, the FDA has (little "a") approved it for the regrowth of hair.

Let's see how they respond by email.

Oh, and Beaner:

If approved, the FDA will mail you a letter, with an assigned 510(k) number, that says they "have determined that your device is substantially equivalent to legally marketed predicate devices...and you may therefore market the device subject to general controls provisions of the (Food, Drug and Cosmetics) Act" Essentially, when they send you the letter, they are not approving your device, they are saying that your device is much the same as other devices (predicates) already approved by the FDA. You will not receive a certificate from the FDA, but this letter will be available on the FDA database as proof to your customers that your product is approved for sale in the US.

If this device is substantially equivalent to predicate devices that HAVE been FDA approved, isn't the logical extension of this that the Hairmax also meets the approval requirements?

Def

 

[jakeb]

So if the Lasercomb was deemed equivalently effective and safe to a previously approved device, what device was that? And why have we never heard of this device?

 

[Def]

I have no idea what those devices are but I have confidence that the FDA know what they're doing and probably know what those devices are!!

Laser hoods, laser helmets etc - could be that type of thing.