Confused About the FDA Clearance of the Laser Comb

Hi. I’m a little confused about the FDA ‘clearance’ of the LaserComb. I’ve read on some websites that this only covers the safety of the product but there is still no proof that it is effective in regrowing hair. Is this FDA clearance conclusive evidence that the clinical trials are correct and the LaserComb does in fact regrow hair? Is there a difference between ‘clearance’ and ‘approval’?

I am not sure about the implication of clearance or approval but it seems to be more of a semantic problem. The FDA has approved / cleared the use of the laser for the purpose of hair growth, but I believe it was approved because the laser has been shown to be safe in predicate medical devices that are similar. I have written extensively about this matter before.