What FDA Clearance Mean for HairMax Laser Devices?

Choosing a product to treat hair loss can be a very difficult decision, especially with all the products on the Internet claiming they are 'proven' to work. There are many bold statements made in advertising hair loss products, weight loss products and dietary products using phrases such as 'clinically shown' and 'clinically proven' to assure the products actually works. HairMax uses the statement 'FDA Cleared' for its laser devices - but what does this actually mean and how does this compare to any other statements?

A simple Internet search, asking the question “What does ‘clinically proven’ mean?” reveals a number of websites that poke fun at this phrase. According to Urban Dictionary, "‘Clinically proven’ may mean virtually anything ... including nothing. A ‘clinically proven’ statement in advertising is an effective sales pitch, usually a vague claim that requires no hard evidence and is not easy to disprove. As long as the mandatory ‘These statements have not been evaluated by the FDA ...’ disclaimer is on the label, it is not necessary to have competent and reliable scientific evidence to back it up.” Hmmm, the plot thickens ! So who are the FDA?

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services and one of the United States federal executive departments. The FDA was formed in 1906 with the aim of reining in long standing abuses in the consumer product market place. The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of food supply, cosmetics, and products that emit radiation. In other words, they are the regulation body that protects consumers against unlawful cosmetics and medical devices.

So if there is a statement which shows that a product has not been evaluated by the FDA who are the regulatory body, then how can anything by 'clinically shown' or 'clinically proven' !

'Clinically Proven' suggests a product has been tested in a clinical trial. It's therefore vital to find out if the clinical trials conducted that “proved” a product works, are available for you to review and study, in order to judge its scientific validity. If the actual study is not available to you, then you should be sceptical in considering the claims being made for that product.

Another consideration of one of utmost importance is whether a hair loss product has compared the active product against a sham device. It is impossible to ‘clinically prove’ a product works in treating hair loss if it was not compared against an inactive device, since there would be no way to know how it compares to “no active treatment”. If a company claims that their product is ‘clinically proven’ for treating hair loss and has not compared their products against an inactive device than that product is NOT ‘clinically proven’ – it is only ‘clinically shown’. The study has no scientific validity.

To gain FDA clearance from the regulatory body, clinical studies have to be submitted for independent scrutiny and review to the FDA. When a company receives FDA Clearance, there are stringent rules and high standards put into place covering all aspects of manufacturing and quality control. There have now been a total of 8 FDA Clearances of HairMax Laser devices for marketing, all of which required the submission of not only safety, but also EFFECTIVENESS based on scientifically designed clinical research studies. No other Laser phototherapy device on the market has anywhere near this number FDA Clearances.

You can be sure that HairMax laser devices are of the highest quality, with the most proof of consistent and predictable efficacy than any other device on the market.

Link to HairMax Clinical Studies: