Washington, DC: A permanent injunction has been granted to the Food and Drug Administration (FDA) against Robert "Larry"Lytle, doing business as QLasers PMA and 2035 PMA based on evidence of false and misleading claims regarding the health benefits of these lasers, which in some cases, reportedly cause health problems.
According to the complaint for injunction filed by the Department of Justice on behalf of the FDA, Lytle has been manufacturing and distributing QLaser devices for more than a decade and markets the devices through private membership associations (PMAs). Lytle and his businesses promote the devices with false and misleading claims that they treat cancer, cardiac arrest, HIV/AIDS, diseases and disorders of the eye and ear, venereal disease, diabetes and many other health conditions.
Although the FDA cleared two of the QLaser devices for providing temporary relief of pain associated with osteoarthritis of the hand (as diagnosed by a physician or other licensed medical professional), the FDA has not cleared or approved any of the devices to treat any other medical conditions. Further, as demonstrated by the evidence presented at trial, use of the QLaser devices according to the labeling could be dangerous to the health of the consumer.
