Where Are The HairMax Lasercomb Studies?

[tbtadmin]

Dear Spencer, Months ago when you interviewed David Michaels, one of the inventors of the HairMax Lasercomb, he said that he was going to give you a copy of the study that Lexington presented to the FDA in order for the Lasercomb to gain market clearance, did you ever see the study, and if so what [...]

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[aiyosh]

How did HairMax comb recieve FDA approval!!

Hi Dr. Feller,

Just wondering, If HairMax comb doesnt work, how did they obtain FDA approval?

Kind regards
Aiyosh

[AlopecianMuse]

Hi Dr. Feller,

Just wondering, If HairMax comb doesnt work, how did they obtain FDA approval?

Kind regards
Aiyosh

Hi Aiyosh,
Dr. Feller responded in another thread previously but I'll paste it here:
LLLT, from a basic physics standpoint, is absolutely unviable. There are several reasons for this, but the most obvious is that the laser light simply can't reach the body of the hair follicle due to the skins natural "optical barrier". Everybodys skin has such a barrier and it is 100% impermiable to laser light, everytime. This was a major oversite on the part of the LLLT industry and it is causing them much trouble.

Here is a link to a short video that proves this point:

http://www.fellermedicaldata.com/Video/laser2.wmv

The physics this video demonstrates is fatal to the LLLT industry which is why they have pressured another forum owner to remove this video from their site.

On two other forums I have asked for LLLT before/after results from the public. After over 10,000 views not a single LLLT advocate could produce even ONE set of convincing photos.

I have asked every major LLLT doctor to produce photos to prove the benefit of the "treatment" they sell to their patients and NONE have responded. The only photos I have seen from such doctors were disceptive at best.

I have also put the question of the "optical barrier" to LLLT doctors, and again not a single one responded. That should raise a red flag in even the most gullable of patients.

Finally, I debated David Michaels, Hairmax boss, on Spencer's radio show and exposed him for being less than knowledgable in the field of laser physics, physiology, electronics, and medicine. He refuses to debate me again publicly. When you listen to the broadcast you will see why.

Stay away from LLLT. Not a single patient who has visited my office for consultation who has reported using LLLT has ever seen any benefit at ANY price.

Aunt Marney,
Laser combes have NOT been FDA approved. Merely FDA cleared.

[aiyosh]

FDA cleared and approved??what is the different?

Thank you for your detail reply AlopecianMuse!! Really appreciate it. whats the different between FDA cleared and FDA approved?? Below from the hairmax link it said the product has obtained FDA clearence...is there a different?? I m confused...

Once again thanks in advance!!

http://www.hairmax.com/ClinicalResearch/FDAClearance.aspx

[AlopecianMuse]

Hi,
Dr. Feller is the man to talk to about that. I just copied and pasted the reply from him because it was so detailed and posted to another thread on the forum.

[breezer]

I don't understand much about lasers , but this I can tell you .

Lasers are used for hair removal , There is a project in the make that is trying to substitute syringes with a laser device , and they already suceeded .

There are doctors that use lasers to cut into the skin ... there are many use for lasers and they can penetrate skin ... Just do your research .

The video it's just stupid , there are very types of lasers . and you can't see with your bare eyes what the efect is .

[TeeJay73]

LOL! Doctor Feller! Well said!! I am completely with you on this one. Your steadfast confidence on this issue, as well as your publicly disclosed, and free-to-see experiments and data, disproves any value to the lasercomb nonsense related to hair loss. I don't understand why people aren't seeing your underlying message as an ethical, awesome doctor: DON'T WASTE OUR MONEY, IT'S NOT GOING TO HELP US!

As an engineer myself (I know you have an engineering background), I can't accept "pie in the sky" rationale for using a product that claims to regrow or sustain hair --- I want solid, scientifically demonstratable proof. And so what if lasers can cut skin? I can also confirm that lasers are used to cut sheet metal --- much tougher than skin. But isn't that irrelevant? Lasers that cut skin or sheet metal aren't the same lasers that would be used to treat hair loss.

I know that if I lived in your area, I'd choose you as my IAHRS surgeon. You're the man!

TeeJay

[breezer]

FDA approval and FDA clearence are two different things. You will have to do your own research to learn the details of the difference.

While there is an implication that FDA clearence confers some sort of governmental validation for the efficacy of laser medical devices for the growth of hair, the details of this validation have been a closely gaurded secret. One must wonder WHY this is.

David Michaels (Hairmax boss) has steadfastly refused to disclose the information he submitted to the FDA to prove efficacy. What's worse, is that he REFUSES to release what the definition of "efficacy" means and what criteria the government required of him. Interesting omissions, aren't they?

While Mr. Micheals has claimed for some time that he would release the "study" he said he submitted to the FDA to meet their nebulous criteria of "clearance", to date and to my knowledge he is still refusing to do so.
This, of course, has not stopped him nor any other LLLT advocate from selling thier wares to a purposefully uninformed public DESPERATE to reclaim their lost hair. And that's a shame.

Breezer,
What an intellectual giant you are. Your considered critique:" The video is just stupid" informs us all of your maturity level. Now, go back to playing with your blocks, the adults are talking.

Now that we agreed that you are intellectual superior than me , we can put personal insults aside .
Of course the video is stupid … just think about it there are many types of lasers and you can't determine what they can do or can't by buying one for 10 $ and pointing it at your hand , the laser industries is worth billions, do you think you have it all covered with that video ? baka ka omae ?
For those who want to instruct themselves and think about it for a second go here :

http://en.wikipedia.org/wiki/Laser

I’m not saying lasercomb works , never tried it and probably will never try . I have heard people saying it does work and others say it doesn’t . you are basing your opinion only in the presumption that the laser can’t penetrate the “optical barrier “ of skin , my question is and if it could ? What if the laser could do what they say , do you think It would work ?

Let the adults talk ? I can only see a bunch of people bowing to what you say not questioning …, if the matter at hands was about hair transplant you are the expert or so they say but it ins’t it is about lasers .
For me everyone is trying to make a buck out of the misery of others . (usa style )

[Tsakalos]

actually when i was deceived in my 23 from a local clinic to stop propecia if i wanted to save my errection, i was told to do several laser treatments. while doing the laser treatments combined with several topicals that clinic put on my WHILE doing the laser for "better" results. so after stoping finasteride and doing this just in 6 months my crown got almost empty. that was 10 years ago. i started complaining to them that their advice ruined my hair and their reply was "This whould happen anyway and since ur poor donor area cant produce a good outcome the only way is the hairpiece. Long story short i was wearing a hair piece from my 24 to 26 (one of the best years in a person's life) and suffering from all the humilation and embarrasment, in the mean time i had many natural hair in the middle which gotten worse by the glue. so after researching i realized what a great victim of them i had become and i ditched the piece started the meds and went to armani for ht.

From personal exprerience although the lasers that different companies offer might not be the same, i think that lasers are a waist of money and scams.

[Andyman79]

Found this, not sure if it's of interest but seems to be a clinical study on the lasercomb

http://www.mydisk.se/hwadump/webpage/Laser/01.22.08.Hairmax%20LaserComb%20FDA%20Clinical%20Study%20Report.pdf

Andy

[someone uk]

i find the whole concept of laser treatment insulting to my intelligence
i mean for one thing the hairmax comb is priced disproportionately for a stick with 5 laser diodes in it
no one has ever justified why the light has to be "laser light", and even that only has 2 reasons, neither can be justified for this reason

laser comb is a scam with an FDA approval

[blowmeup]

Hairmax laser comb is NOT FDA approved!!!

It’s FDA cleared which is a big difference.

[Andyman79]

It’s FDA cleared which is a big difference.

Am I right in thinking that to gain both FDA Clearance and Approval you would require a study to show safety and efficacy but Approval is not given without a clinical study to back the study up?

I would be interested to know the actual definitions if anyone can help.

[KeepTheHair]

Andyman

According to my understanding I think that FDA cleared means that it has been cleared for SAFETY.

FDA Approval is it has been approved to DO SOMETHING like prevent hairloss and regrow hair.


The HairMax LaserComb has been approved and cleared I think. I was 100% sure I was getting it until I read the varied opinions in this thread...


I have seen good reviews..it's FDA approved and seems like a good product...

Are you guys really that sure that it does not work? I really want to try it but I mean... it's insanely expensive in time and money.

Thanks

[Winston]

The HairMax Lasercomb is not FDA approved!

What are 510(k) Clearance and Premarket Approval?

Jason Smith
Stephen Barrett, M.D.

All manufacturers who wish to market devices in the United States are required to register with the FDA and are subject to periodic audits. This article describes the marketing pathways they can choose.
Device Classification

The 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act created three categories of medical devices, based on the level of risk:

Class I: Generally, these are simple devices with minimal risk to the user. Almost all of these devices are exempt from FDA clearance or approval. Examples: enemas, crutches, elastic bandages, bedpans.

Class II: These devices pose a moderate level of risk to the user. Almost all of these devices require a regulatory submission before they can be legally marketed. As a rule, class II devices require 510(k) submissions. Examples: condoms, intravenous administration sets, sutures, inflatable blood pressure cuffs.

Class III: These devices pose a serious level of risk to the user, mostly because they are implants or sustain life. All of these devices require a regulatory submission before they can be legally marketed. As a rule, class III devices require a PMA (Premarket Approval) submission (described in further detail below). Examples: implantable pacemakers, blood vessel stents, breast implants.

Registration is required regardless of the classification. The method chosen depends on what the manufacturer wishes to claim and whether similar devices have been cleared or approved.

510(k) Clearance

The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device (one that has been cleared by the FDA or marketed before 1976). The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Human data are usually not required for a 510(k) submission; this decision is made at the discretion of the FDA. Laboratory testing is almost always a requirement. Depending on the type of 510(k), the law gives the FDA either 30 or 90 days to clear the device, ask questions, or reject the application.

Manufacturers may also submit a 510(k) if they alter their device. Not all changes require a 510(k) submission. In general, changes to a device’s intended use, contraindications, or basic operation require a new 510(k) clearance. Changes to blood-contacting materials, sterilization method, or performance specifications may also require a new 510(k).

The FDA does not “approve” 510(k) submissions. It “clears” them. It is not legal to advertise a 510(k) cleared device as “FDA-approved.”

Premarket Approval (PMA)

A PMA submission is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Human use data from a formal clinical study is almost always required in addition to laboratory studies. The FDA is required to approve, question, or reject the application within 180 days. Changes to a PMA-approved device may require a PMA supplement or even a new PMA. Manufacturers have far less leeway in modifying PMA devices than they do for changes to 510(k) devices. PMA devices can be legally advertised as “PMA-approved” or “FDA-approved.”

Checking Documents

Submissions for 510(k) and PMA are public documents except for portions that contain trade secrets, confidential commercial/financial information, or information that is personal and private (such as patient records from clinical trials). For both types of submissions, the FDA maintains searchable online databases that contain only a small amount of information. Additional documents that are releasable can be accessed through a Freedom of Information (FOI) request. The first time an FOI request is made for a submission, the FDA notifies the original submitter, who is then allowed to delete proprietary and personal information.

If searching an online database, note the current manufacturer or distributor may not be listed as the submitter in the database. This happens because the FDA database is not updated when ownership of a 510(k) or PMA is sold or transferred between business entities. So submitter information refers only to the company that made the submission. Therefore, if company A gets PMA 123 approved for their product, but later sells that product to company B, the PMA database for number 123 will list company A as the submitter, even though company A might not have made the product for many years. Also, foreign companies can have domestic firms make submissions, and consultants who write submissions might be listed as submitters.

Defrauding the FDA

Manufactures of quack devices sometimes seek clearance without telling the FDA that their device will be used differently from the predicate device. For example, several devices said to measure skin resistance are accompanied by software that fabricate diagnoses and recommends products. This set-up is illegal because the basic device has not been cleared for such purposes. In addition, the FDA would consider the software to be a separate device—very likely in Class III—that would require premarket approval.

Mr. Smith is employed in the medical device industry and has been writing regulatory submissions for over 14 years.

This article was posted on April 12, 2008.

http://www.devicewatch.org/reg/reg.shtml