It seems that the FDA should not be in the business of “clearing” anything that is not scientifically substantiated. There is an awful lot of stuff out there that won’t kill. I’m sure it’s obvious that “clearing” such substances gives charlatans a “green light” to deceive and rip people off.
(One would think that the FTC would ask the FDA to knock it off, as this creates a great deal work for them (the FTC), i.e. investigations, lawsuits etc. It raises the question of what the FDA gains from providing such “clearance” status? If it’s money, I guess that this, then, overrides principle, to say nothing of wasted tax payer dollars used to prosecute the “cleared” crooks.).
I believe the hair lasers received the FDA clearance by a loophole, with the technology being grandfathered in as a device marketed before 1976, when the Medical Device Amendments of 1976 gave the FDA the authority over devices like this. Remember, these hair lasers do not have FDA approval, but simply FDA clearance.
The sellers of these lasers make medical claims of benefits and this alone falls in the scope of FDA activities. The FDA is responsible for claims of safety and effectiveness. Think about it. If someone recommended the LaserComb to prevent stroke or Alzheimer’s, they would have to be able to prove it.