We received the following information from Leonard Stillman at Lexington International and wanted to share it:
NOT ALL LASERS ARE THE SAME AND NOT ALL BRANDS OF LASERS ARE THE SAME
There has been a lot of publicity about lasers and their use in all areas of medicine, from surgical uses to uses for cosmetic indications such as hair growth, hair removal, wrinkle effacement and cellulite reduction. Recently, there have been an ever increasing number of home use laser devices introduced that make all sorts of unproven claims.
The action of these lasers is dependent on the TOTAL output of laser wavelength they emit and is NOT dependent on the number of lasers used to give this output. In fact, if a laser is designed for hair growth, total laser output has to be specific at 655 nm to be effective. For a laser to destroy or remove hair, they have to have a higher wavelength output in the visible light spectrum of around 800 nm. And of course, lasers used in surgery to remove lesions have to have an even higher wave length of over 1000 nm to work. So you can see that just a little higher wave length than that which is required to work for a specific condition, can actually cause a different reaction as between hair growth and destruction.
It is important to know these facts about lasers and what they are used for because there is so much conflicting information on the web about lasers and what they can do. The big “buzz word' in hair growth is the allegation that the more lasers a device has, the better it will work to grow hair. As mentioned above, this is not true as it is the TOTAL energy output that is important and NOT the number of lasers it takes to deliver this energy. In fact, more lasers in a device could in fact be delivering too much energy and cause hair loss rather than hair growth because of excess energy delivery.
So how do you know what is the best laser to pick for treating a specific condition, particularly for home use? The answer is simple – you should ONLY consider any home use medical device that has specific FDA clearance for marketing. While there are a lot of home use devices available on the web making all sorts of claims, there are very few that have FDA clearance. As an example, while there are many devices advertised for hair growth, the HairMax LaserComb is the ONLY home use laser phototherapy device that has FDA & TGA clearance for marketing for the promotion of hair growth for men and women. Likewise, while there are many devices that claim efficacy for hair removal, only a couple of them have FDA clearance. It is that simple……DO NOT buy any home use device that does not have FDA or TGA clearance, period!
So why is this FDA & TGA clearance so vital? The reason is that this means that a 510(k) submission has been submitted to the FDA for the device and has been reviewed by that agency to assure that the device is safe. In many cases, as with the HairMax LaserComb, efficacy has been proven in well controlled clinical studies and these studies were pivotal in the clearance of the device by the FDA.
In addition to this review and clearance, the FDA requires and monitors strict manufacturing and quality control standards. This oversight assures that the energy put out by these devices ALWAYS complies with the energy output for which they were cleared for marketing. Using any other devices that do not have this clearance means you do not know how they are made and in some cases you do not even know who makes them since they use a mail drop address. FDA clearance for marketing is specific to the specific brand and is NOT transferable to other devices of its kind. There is no such thing as an “FDA approved brand of laser'!
So while the various lasers on the market, particularly in the home use category can be confusing, it is easy to eliminate most of those advertised for consideration because they DO NOT have FDA clearance SPECIFIC to their brand. Be sure to do your research and assure that the company marketing the device you are considering has spent the resources to achieve FDA clearance for marketing the right to make claims for efficacy. Only in that way can you be confident that they will do what they are designed to do and are a high quality product.
We hope that you will post to clarify the information about lasers for hair growth.
Leonard Stillman, Director of Professional Services at Lexington International, LLC manufacturers of the HairMax LaserComb.
This posting is not for commercial purposes but to provide further information about laser phototherapy for treating hair loss.
