From what I understand, the laser comb's been approved by the FDA because it doesn't harm the user. I don't believe the FDA ever approved it as a hair loss treatment, but got it in under the "substantially equivalent" clause.

Basically, it does what something else already did and doesn't cause harm. But if some other laser already worked for hairloss, how come we never heard of it?

It's a scam.

More great stuff on Dr Rassman's website, criticizing Lexington's failure to make details of their clinical trials public or have them peer reviewed, as would normally happen in such circumstances.

Critical of the LaserComb's Claims and FDA's Rulings
"As a physician, I'd like to amplify on a previous blog, which emphasized that detailed data on the benefits of the LaserComb is not available and thus makes it difficult to evaluate its benefit beyond anecdotal experiences. In addition, the manufacturer makes claims likely to be criticized as unsupportable if similar claims were made for a drug and, to me, employs classic marketing techniques designed to give as little information as possible. When the manufacturers of the LaserComb report their claims in peer-reviewed, scientific journals where the data can be evaluated by the public, it will allow me to better evaluate the risk/benefit is. In addition, claims made by the manufacturer ("greater than 90% user satisfaction reported!") are the type of marketing statements that are impossible to evaluate without context."

"As an experienced clinical investigator, it is misleading for Lexington to argue that they "had to prove to the FDA, under the same statistical scrutiny as both Propecia and Minoxidil, that the HairMax was effective in increasing ??Hair Counts' in men with Androgenetic Alopecia." ... One wonders why this data was not submitted for puyblication immediately upon completion of the study or at least submission of the regulatory filing (as is common practice by biopharmaceutical companies)."

"There are a couple of things that I find odd about this study, for one, the study was completed in November of 2005, yet they didn't submit it to the FDA until September of 2006."

Continuing the LaserComb Debate...
"Great that the single pivotal study is being written up for publication. This should have taken 1 week and been done a long time ago. It is highly atypical that a device or drug is approved without the study being published (before approval) in a peer-reviewed, scientific journal. This is truly the only way for physicians and patients to understand the effectiveness and safety profile, and make an educated decision. It is so atypical not to publish such data that the absence creates skepticism, whether deserved or not."

That last comment refers to Lexington's "promise"
We are currently drafting a medical review of the study to be submitted to a peer-reviewed journal. We have every intention of publishing the study and making the full results available for public scrutiny.

Well we all look forward to that. But even if they did this today, why it has taken them so long!