The HairMax LaserComb’s Misleading Advertising Strategy

HairMax first caught my attention while I was looking for a hair loss treatment that would help me stop my balding condition. Among the products on the market, the HairMax LaserComb ‘claims’ that they are the ‘only FDA-approved’ laser device for treating hair thinning and stimulating hair regrowth.

When I saw the word ‘FDA-approved’, it made me think of trying out the product because it might effectively regrow my hair. As a consumer, I was convinced to buy the product; hence, I paid out $500 to get hold of this so-called hair growth device.

When I received the package a couple of days later, I was very excited to use it as part of my hair loss treatment regimen. However, my excitement turned to frustration when in the 4-month period of my treatment I still wasn’t able to see any improvement.

With that, I began to search for consumer reviews about the HairMax LaserComb. During my research, I have read tons of comments, some of them are positive and others are negative, some even reacted that HairMax LaserComb is not at all effective—as it claims to be. I also discovered something interesting posted in a forum. One of the users found out a report from the FDA about the HairMax LaserComb.

‘The FDA Granted Class II Clearance 510(k) K103368 of these medical devices for sale in the USA for the “Treatment of Hair Loss and Promotion of Hair Growth” in males’.

If you are considering buying the HairMax LaserComb, you should read the FDA report first. There are beliefs that Lexington International, LLC—manufacturer of the HairMax LaserComb—is using misleading advertising strategies to convince the consumers that the product has the support of the FDA that their product can effectively regrow hair.

The truth is, FDA does not grant ‘approval’ on a product based on a 510(k) submission, it only CLEARS the product for marketing. It is, therefore, NOT LEGAL to advertise a 510(k) cleared device as ‘FDA-approved’.

Based on that statement, HairMax is only permitted to be advertised or marketed as a product intended to grow hair. However, the FDA did not state that the product is EFFECTIVE in hair regrowth. An FDA-Approved or Premarket Approval (PMA) submission is used to demonstrate to the FDA that a new or modified device is SAFE and EFFECTIVE. This standard is higher than is required for 510(k) submissions.

With that, we can arrive at a conclusion that the HairMax LaserComb is ‘cleared’—not ‘approved’—as a product that may be promoted to treat thinning hair and that any other laser device on the market could apply for the same ‘approval’ and the FDA would undoubtedly offer the same rights.

When I read this report, I began to wonder if the HairMax LaserComb is indeed effective to stimulate hair regrowth. I mean with the 4-month hair treatment period that I have undergone, surely if a product is effective, I could have seen some positive result no matter how small, right?

Source : The HairMax LaserComb’s Scam Misleading Advertising Strategy