Can a Laser Be FDA Approved For Hair Loss Treatment

I saw a website from a ‘company’ in the field of hair restoration, where the doctors were advertising several types of lasers for the treatment of hair loss saying that their devices are FDA approved. Does this mean that these devices have been tested by the FDA and actually work?

We addressed the subject of FDA regulation with hair lasers many years ago here and here. The FDA never really approves such a device confirming that it grows hair, but in this case they cleared it to be safe for sale. It is unfortunate that some doctors seem to promote the idea that such devices are ‘approved’ by the FDA for certain hair loss treatments. The FDA does not actually test these devices on its claims of growing hair, but place the burden on the seller or manufacturer to demonstrate safety and effectiveness. In this situation, the FDA clearance for use of terminology for Low Level Light Laser Therapy seems to have faltered.