It can be very overwhelming to try and find your way through product claims, marketing campaigns, and advertisements.  Sometimes it feels like if everything they say in the commercial is true – then it would seem like I would have heard great reviews from someone I know.  I could be way off base, because when there is new technology out there it takes time for it to infiltrate the market.  Hopefully this article will give you some information about the Laser Comb so you can decide for yourself.

 The company that makes the laser comb implies that the device has been apprived by the FDA for hair growth in males with a specific type of hair loss.  So how do we know if this is really true or not?  How do we decide what exactly the FDA has approved?

 One thing is for sure, there are not easy answers to those questions.  I will outline a little bit of what I do know for sure.  The HairMax LaserComb has received clearance from the FDA in accordance with the FDA 510(k) regulations. 

 Figuring out exactly what 510(k) clearance means is difficult.  According to some, it merely means that the device is safe to use.  According to others, it means that it is okay for the company to market the product according to their specific claims (ie hair regrowth). 

 According to the FDA, “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device..”  The devices that are listed on the 510(k) form for the Laser Comb do include devices that have nothing to do with hair growth.   So it does leave you to wonder if the FDA clearance that your device is “substantially equivilant” to A&M Hair Removal, is this really the kind of approval you want to promote? 

 Click here to view the actual HairMax Laser Comb 510(k) approval from the FDA.  As you can see, on the last page of the approval letter from the FDA, they have approved Lexington to market the device with the intended use “to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of IIa to V and Fitzpatrick Skin Types I to IV.”

 So the company is not lying or misrepresenting the truth, which is great news!  The FDA has given permission for Lexington to market the laser comb in this way.  However, I see no evidence that says this is because the FDA agrees that the device is effective.  This is something you will have to figure out on your own I suppose.