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Laser Combs for Hair Loss?

Posted by Imagine Clinic for Hair on January 25, 2011

Laser hair combs, and specifically the MEP-90, are FDA approved. So they must work … right?

Let’s take a look at what this approval actually means, though. Laser comb manufacturers are advertising their product as “FDA approved”.  This may appear that the product is registered with the FDA and has FDA approval, like a prescribed medication.  Let me explain why this may be misleading.

First of all, when laser combs claim to be “FDA approved,” what they really mean is “FDA approved for marketing.” Just because the FDA gives the “ok” to market laser combs, they are not saying that the product will work. In other words, the FDA is not going to design, perform or monitor a clinical study to determine the long-term results.

In order for a manufacturer to be able to market their product, they need to have the FDA clear that the product is ok to market. A form called a 510(k) is part of the application process to have marketing approval by the FDA.  Part of the 510(k) application process is to show that the product being submitted is similar to other products. This is so the manufacturers do not have the burden of showing that the product is efficacious (medical term meaning that the drug/device will do what it claims to do).

So, if the manufacturer can show the FDA that other similar or “equivalent” devices exist and they are “substantially equivalent” then the manufacturer does not have the burden of proving the actual effectiveness of the product.

So, what are these “substantially equivalent” devices that have been cited for the FDA  approval for marketing laser combs? Take a look at these products below. You will get a kick out of it. However, the humor is immediately negated when we realize that patients and consumers alike are paying hundreds and even thousands of dollars on these laser combs trusting that their results will “come in time” after multiple sessions and countless hours under a blinking light. Even more outrageous is the daring boldness of those who sell, suggest and prescribe these laser combs.

To the right we have the Robi Combi. This device is used to remove head lice. The FDA finds this as a predicate device similar enough to the laser comb to validate marketing the laser combs. To the left we have Evans’ Vacuum CapThis device was also listed as “substantially similar” to the laser comb. It claims to suck the hair out of the patient’s scalp.

Or better yet, we have The Raydo and Wonder  Brush and Violet Ray device (to the right and below) that are contraptions from the turn of the 20th century that claimed to be magnetized in such a way that would coax new hair out of the scalp. Manufacturers must have been feeling pretty tenacious to cite these outdated and undoubtedly ineffective products as part of getting FDA approval for their laser combs.

The MEP-90, a laser that is marketed for hair loss treatment, also has FDA clearance. But remember, the FDA has just cleared it for marketing, not cleared it as efficacious. But the predicated devices on the application are based on the laser combs which are based on above outdated and ineffective devices.

As far as results from the MEP-90 laser system, researchers attempted to prove with accurate and positive clinical results that the MEP-90 works. However, researchers only studied the results of hair loss and regrowth up to 6 months which is only up until the end of 6 month placebo effect that one sees in hair studies.

What is the placebo effect in hair studies?  An unusual and supervising phenomenon occurs to subjects in the first few months of a study that shows increased amount of hair, even if all they do is rub water into their scalps. Because of this, and allowing for this placebo effect, it’s important for studies to go beyond a year. This time frame allows the placebo effects to disappear and the true results take their course.

Bottom line: If you are going to spend money, stick with the only FDA and clinically
proven choices: Minoxidil, Propecia and hair transplant.

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