The US Food and Drug Administration (FDA) considers the use of cold laser therapy experimental and currently is allowing it to be used in studies for temporary pain relief. It is thought that this type of therapy relieves pain, inflammation, and helps heal wounds. The evidence at this point is far from conclusive.

The FDA does not allow statements that cold laser therapy can help or cure a disease if scientific studies have not established it as fact. Well controlled studies are currently underway and if they prove that cold laser therapy is successful they may eventually become part of conventional medical care.

Several web sites reported earlier this year that the FDA approved the use of a laser device for regrowing hair for sufferers of hair loss. The FDA database does not list any approval, but does clear a LaserComb device via a 510(k) notice for marketing.