This is on the FDA's website about what a 510(k) is. To me, it seems like they are trying to say that the FDA has tested their product and agrees that it does work for re-growing hair.

Research the claims to find out the real truth. Lexington International makes the device called the HairMax LaserComb. Some answers can be found with a little bit of ing. Every day consumers are bombarded with radical claims from companies selling products and devices that we absolutely must buy. What Does FDA 510(k) Clearance Mean For Laser Comb. When I started to look into what exactly a 510(k) clearance is, I got really confused.

However, it is important to become an educated consumer.

"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." So really, it seems more like a comparison to a safe product rather than a. The type of clearance from the FDA that the laser comb received is called a 510(k). They advertise that the FDA has approved their device.

Most of the time, their claims seem legitimate because obviously a company would not say anything bad about their own product.