I know Lexington's HairMax LaserComb has been discussed at length, but I'd like to share my research into this. I am not involved within the hair industry in any way and am not medically qualified. But I do confess a bias as my personal opinion is that laser cannot possibly be effective. This being so, instinctively I have to question the validity of Lexington's trials and hence the level of scrutiny that the FDA applied when granting its "approval".

Therefore my research concentrated not on whether it can grow hair, or whether Lexington's clinical trials are sound and free from bias. Rather my investigations sought to discover what exactly we can reliably infer from this FDA "approval".

One point to make clear first. Everywhere you look - forums, media, sites promoting or selling laser ??“ they all refer to it as "approved" or "endorsed" by the FDA. The one exception is Lexington, who correctly refer to it as "cleared", and with good reason as this is not just a question of symantics ....
From the FDA website:
A manufacturer who wishes to sell a new type of medical device, or one that has new uses that represent a high risk to public health, must submit a Premarket Approval (PMA) application. A PMA must include valid scientific evidence showing that the product
?· does what it claims to do (is effective); and
?· does not present unreasonable risks to the patient.
Most new medical devices are similar to products already on the market and do not represent a high risk to public health. Manufacturers wishing to sell these products must submit a Premarket Notification (also called 510(k)). This process is for lower-risk devices that require less rigorous testing and evaluation. A 510(k) must include information demonstrating that the new device is very similar (substantially equivalent) to another device already on the market.
Some low risk devices with well-established records of safety and use receive no review.
Medical devices that go through the PMA process are called approved. Those that go through the 510(k) process are called cleared.

PMA is for drugs (e.g. Minoxidil & Propecia) and for high-risk (Class III) devices. The 510(k) is for lower-risk (Class I & II) devices, and is generally a much faster, cheaper way of getting a device onto the market. The HairMax is a Class II device and went through the 510(k) process. You'll note that whilst the FDA's summary makes clear the need for a PMA device to be scientifically proven to be effective, there's no such proviso stated here for a 510(k).

Class I/II devices that were legally marketed prior to May 28 1976 (i.e. before the enactment date of the Medical Device Amendments) do not require a 510(k) to proceed for market. The assumption is that as these preamendments devices have been around for a while, they must be safe, even though the FDA will have no real idea how effective they are because they've never assessed them. This is the first big clue that the FDA allowing class I & II devices to be legally marketed is more about safety than effectiveness.

A 510(k) works on the basis of finding a legally marketed device (a predicate) to which it is substantially equivalent (SE) ??“ i.e. "is at least as safe and effective". So we do now have a definition of how "effective" a device must be, in that it has to be at least as effective as the predicate. But how effective does the predicate have to be? Could it be that the predicate is not effective in the slightest?

The FDA define SE as when the new device
?· has the same intended use as the predicate; and
?· has the same technological characteristics as the predicate
If so, it is automatically deemed to be SE and hence will be granted a 510(k) clearance to market. In most cases, the predicate is a preamendments device of which the FDA has absolutely no idea how effective it is, to a high level of scientific certainty or otherwise. This is concrete proof that by the FDA's own criteria, a 510(k) should not be taken as any kind of proof of efficacy.

The FDA website also gives another criteria for SE that can be applied
?· has the same intended use as the predicate; and
?· has different technological characteristics and the information submitted to FDA;
o does not raise new questions of safety and effectiveness; and
o demonstrates that the device is at least as safe and effective as the legally
marketed device.
Although the FDA website does not mention it, it seems there is a third criteria that a device can fulfill, which is a variation of the second whereby the device has the same technological characteristics as the predicate, but has a different intended use. It is this third criteria that Lexington used in order to claim SE and hence a 510(k) clearance.

For devices that fall into these latter two categories, evidence in the form of clinical trials may be submitted, although this only happens in a minority of all 510(k) cases, especially as there are other forms of evidence that are acceptable. But does this mean that the FDA would apply great scrutiny to these clinical trials, ensuring that they are scientifically sound and prove a high level of efficacy to a high level of scientific certainty, in the same way that they presumably would for a PMA? It simply does not make sense that they would because:
<UL TYPE=SQUARE>- what would be the point of having this fast-track 510(k) for such devices? Why not just go through the PMA process and get full-blown approval?
- the FDA are clearly not too bothered about proof of efficacy for the vast majority of 510(k) applications, so why would they apply such strict criteria and scrutiny for this minority group?
- the FDA website for 510(k) applications says very little about clinical trials. There's no guidelines on when exactly they'd be required, what format they should follow or what level of efficacy should be established (just that is has to be "as effective" as the predicate).
- The only information required, according to the FDA website, is summary information of any clinical trials, whereas the submission of the full trials would surely be a mandatory requirement if the FDA always undertake a thorough review.[/list]The only details on the FDA website relate to the completion of the "510(k) summary" form, and indeed only summary details are required:
<UL TYPE=SQUARE>(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence;
(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and
(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section.[/list]There's absolutely no mention that full details must be submitted; only a summary of any trials conducted. Did Lexington submit the full trials for scrutiny, even though it may not have been a requirement to do so? Their 510(k) only contains summary information. The FDA refuse to confirm or deny whether they did, saying it is confidential information. So there's absolutely no confirmation forthcoming from the FDA as to whether they could have applied a high level of scrutiny never mind whether they did. So it could be that the FDA were mostly happy to take these at trials face value; just providing the applicant had obviously made some attempt to put the device to the test. This doesn't mean they were negligent, but rather to do anything more involved was simply not within their remit when assessing a 510(k) application.

According to FDA rules, how effective does a device have to be before they'd grant clearance? Would it be sufficient to prove that a device is 1% effective in 1% of the patients, for example? The FDA website says that to establish SE, it simply has to be as least as effective as the predicate, which in Lexington's case is "not at all" because their predicate laser is not marketed for hair growth.

An indication of the difference in the FDA's approach when considering clinical data for a 510(k) compared to a PMA is touched upon by their disclaimer in within their DATA REQUIREMENTS FOR 510(k)s guidance notes:
While the Center has concluded that it should sometimes require performance testing data in order to confirm that a new device is SE, the 510(k) review process is not a substitute for premarket approval, and the Center does not attempt to address all of the issues would be answered in a PMA in its review of 510(k)s. Data in a 510(k) should show comparability of a new device to a predicate device, whereas demonstration, in an absolute sense, of a device's safety and effectiveness, is reserved for PMAs.
So clinical data is used merely to establish SE to a predicate device that may not actually be effective at all. This is completely different to the PMA process that hair regrowth drugs such as Minoxidil and Propecia have been through, for which the purpose of clinical trials is to establish effectiveness in the "absolute sense".

It is clear that a 510(k) clearance is just an OK-to-market given to a manufacturer because it complies with premarket notification regulations, nothing more. It does not represent any kind of approval or endorsement by the FDA, and they've taken safeguards to ensure that it is not represented in this way. Within the FDA's letter granting Lexington clearance (which states this was due to "finding of substantial equivalence to a legally marketed predicate device", as opposed to "proven to be effective"), it makes clear that this is subject to them complying "with all the Act's requirements" making specific reference to 21 CFR Part 807 and in particular to sub-section 97:
Sec. 807.97 Misbranding by reference to premarket notification.
This states that the granting of a 510(k) clearance "does not in any way denote official approval of the device. Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding."
I'm sure they wouldn't have this restriction if they were completely satisfied of the device's efficacy, and indeed this restriction does not apply to PMA devices.

There are other similar references too, including on their "Misbranding" page, which lists one of the abuses as
"If there is any representation that created an impression of official approval because of the possession by the firm of an FDA registration number."

Everyone selling laser obviously believe that "approved" sounds better than "cleared", even though this is an abuse and contrary to the terms under which the 510(k) was granted. I personally believe that even "cleared" is misleading as it still gives a false sense of FDA endorsement. It seems that the FDA agree as they've confirmed that firms may not advertise or promote their 510(k)-cleared devices as being either "FDA-cleared" or "FDA-approved".

Unfortunately, in my dealings with the FDA, I've found that they're very reluctant to explicitly acknowledge the limitations of the 510(k) process, and that for most devices, they really can't have any idea of just how effective it is. Ask them a question that would involve an admission to that effect, or conversely whether one can deduce from a clearance that the FDA were satisfied of its efficacy to a high level of scientific certainty, and they'll ignore it. Pursue them for an answer and they'll side-step the question. I think they fear that the public will perceive them as being negligent for granting clearance on such a basis, whereas really it's just outside of their remit.

This seems to particularly apply to questions about the Hairmax as they're probably aware of the media bonanza it sparked, and how their 510(k) clearance has led to a massive public misconception. Sure they'll say that Lexington had to provide scientifically sound clinical trials that prove it works, and they were satisfied that they did this - would you really expect them to say otherwise! But that's not the point. Ask them to elaborate on the level of scrutiny and analysis they applied and they'll ignore or side-step the question. They won't even admit whether they ever had sight of the full trials.

Hopefully my research has established that no one can reliably infer that a device has been proven effective to a high degree of scientific certainty, purely from a 510(k) clearance, and that the FDA's own rules prevent it from being portrayed as any kind of approval or endorsement. In particular, no one should draw any inferences about the level of scrutiny or analysis applied by the FDA when assessing Lexington's application, unless the FDA are willing to provide specific details.

My final say on this lengthy but hopefully informative thread is to make reference to The Journal of the American Board of Family Practice article entitled "Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice"
http://www.jabfm.org/cgi/content/full/17/2/142
Jotronic has already do an excellent summary of this article, highlighting and interpreting the most relevant parts; well worth a read
FDA Approval

Here's some key quotes from it:
<UL TYPE=SQUARE>- For this type of approval, a device need only do technically what it claims and be reasonably safe. A device that delivers electric current to the skin can be considered "effective" without asking if it relieves symptoms.
- One way of prioritizing was to focus first on safety. Evaluation of effectiveness, in many cases, was reduced to engineering performance: does the device hold up under its intended uses, does it deliver an electric current as advertised? The potential benefits for relieving pain, improving function, or ameliorating disease did not generally have to be demonstrated.
- the products that have been pushed through 510(k) are astonishing
- For the first 5 to 10 years after 1976, this approach (i.e. substantial equivalence to a predicate device) made sense. But in 2001, 25 years after the Medical Device Amendment, does it make sense?
- The process by which the agency decides if something is "equivalent enough" to be approved by the 501(k) mechanism is subjective.
- Because pre-1976 devices were not subject to any rigorous tests of clinical effectiveness, a newly approved device may be equivalent to something that has little or no therapeutic value. As an example, the FDA still receives 510(k) applications for intermittent positive pressure breathing machines. Yet a thorough review by the federal Agency for Health Care Policy and Research found that these devices offer no important benefits.[/list]Would especially welcome comments from anyone who has been through the 510(k) process, or who knows anything about the reliability of Lexington's trials. Are they available for anyone to assess? They're not on the government's clinical trials database. Also, is there evidence to suggest that Lexington have abused this clearance by portraying it as an FDA endorsement?

got cliff notes for that? No good stuff man really. I dont think its as effective as Propecia or minox. But I do think drawing blood to the follicles via Lasers/sun whatever has got to be good for the hair. I dont have one but have thought about getting one on ebay from some disappointed owner that hates it.

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I spent ??1000's on laser treatment - the biggest scam of them all! Save your money bro

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See my results --->>My Hair Loss Website

I am not a medical professional and my words should not be taken as medical advice. All opinions and views shared are my own. "Research-Research-Research"

In my opinion you will get limited results if any using laser combs/brushes.

Out of the thousands of guys and girls who use them there are very few who post a positive result and most take other meds as well at the same time to promote hair growth.

Cybernaut,

You make some great points, especially that the FDA has "cleared" (not approved) the Hairmax lasercomb.

Apparently Lexington did release a clinical trial but it was not publicly released since they had the option to submit it privately. Of course the obvious question then is - why if this proves the lasercomb's effectiveness, why not release it to the public? Another question is WHAT was exactly submitted to the FDA? Was it the entire clinical trial or just the supposed results?

The Hairmax lasercomb has been deemed "substantially equivalent" to other products on the market and has been "cleared" for safety.

In my opinion, whether or not the lasercomb or laser hair treatment of any kind is effective to treat baldness requires more evidence before I buy into it.

The primary problem I have is the marketing hype of the FDA "approval" and since "approval" isn't even the right word, it's misleading. But isn't that the world of marketing in general?

Thanks again for taking the time to post this.

Best wishes,

Bill

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To learn about how I restored my hair, view my my hair loss website.

Remember, true beauty radiates from within, not from the skin.

I am not a medical professional and my words should not be taken as medical advice. All opinions and views shared are my own.

Thanks for your comments all.

Would still love to hear from anyone who has been through the 510(k) process, or who knows about lasers and how they can possibly be effective in hair growth, or who knows anything about Lexington's trials.

Hair expert Tony Pearce says
Having previously been requested to become involved in a clinical trial for laser therapy FDA approval, I know how manipulated these ??clinical trials' can be. You pre-select your subjects in age, minimal hair thinning, total health check, supplement them with protein and nutrients until it comes out their ears ??“ and you're ready to go.
??98% success rate' can mean ONE additional hair has been counted within a one centimeter-square designated area of the subject's scalp ... In my opinion this is statistical crap that means nothing to the everyday consumer.

He writes some good stuff on http://www.hairlossclinic.com.au/blog/

Anyone wishing to read this particular blog from Tony Pearce is too late. It has just been removed whereas all of his other posts still remain! Maybe he had threats of legal...

But there's other good stuff on the link http://www.hairlossclinic.com.au/blog/.
Have a read of Setting The Record Straight ... http://www.hairlossclinic.com.au/blo...cord-straight/ It's a scream!

Cybernaut, great post. Just speaking for myself, I've used the lasercomb for about 4 months now. Honestly the only big difference I see is that I stopped shedding. There's not nearly as much in the sink as there used to be. But it all depends on what you want out of life. If it stops the shedding, thats good enough for me for now. But I definitely don't see the "miraculous" hair growth that you see in the ads.

Have found some great stuff on Dr Rassman's website http://www.baldingblog.com/index.php?s=lasercomb

Analyzing the Results of the HairMax Laser Comb
Dr Rassman has performed an analysis of the before/after photos of the clinical trial patients. http://www.lasercomb.net/beforeafter.htm

The first set are normal headshots. I struggled to see any real difference in many, and in some the head was tilted more forward in the after photo, an old trick to make the hairline appear more advanced. Dr R's observations are
"I looked carefully at these, and there is a real question in my mind as to what I am seeing. A few of these pictures have longer hair that is possibly responsible for the changes that I can see. I wanted to get an enlarged version of the photos to see the details that would tell me what I was looking at, but they are not available on the site. The first before/after set in the group are a good example to start with. There is a suggestion that the scalp has coloring to it (Dermatch or something similar), but as I can't enlarge the photos, I can't try to determine what it might be. Could the difference be lighting or combing style? I don't know, honestly. Many of the photographs suggest styling differences. In no case was there any significant change in the hair coverage, though. Either the person had plenty of hair when they started or there was not enough hair when they finished treatment. "

The second set are the clinical trial macro photos. Dr R's observations are
"We analyzed two sets of the before/after high-powered magnification photos, which also includes the data that they based their research upon. The actual hair counts as they did them are well presented and can be seen by magnifying the circular areas of hair density assessments. Each hair grouping was identified, numbered, and the authors put the actual count on each follicular unit as they made the measurement. They did not separate or identify those hairs that were miniaturized. Because all of the information is present in the material presented on their website, it was easy for us to repeat their measurements and to ascertain if their numbers corresponded to an independent assessment. "

He gives full counts on his website, and disagrees with the count claimed by the clinical trials on each of the before/after photos. Dr R concludes
"Statistically, the percent difference between the before and after photos (according to my count) is insignificant. Therefore, in the first set of photos the LaserComb made no real difference.
In the second sequential set of photos, I discovered that the after photo actually had less hair than the before photo"

Whose count should we believe. Dr R claims his because
"I am comfortable saying that I am one of the world's experts in hair densitometry. I can prove this as I am the inventor of this technology and hold the U.S. Patent on the instruments used by HairMax (or Lexington International) to demonstrate their findings (see: USPTO.gov). With that being said, I reviewed our findings and agree with our counts. I believe that HairMax's photos do not show any objective evidence of hair growth on the first two sets of data and that the numbers that they derived do not correspond to the assessments made by us. Lots of good hype if you're into it."