Laser Manufacturer Ordered by Court to Cease Operations
A laser manufacturer that produced unapproved products will no longer be able to conduct business.
Last week, a federal judge in the U.S. District Court for the District of South Dakota granted the Food and Drug Administration (FDA) a permanent injunction against 2035 Inc. and Robert "Larry" Lytle, doing business as QLasers PMA and 2035 PMA. The decision prohibits the manufacture and sale of "QLaser" low-level laser devices, which have not received FDA approval.
According to an FDA complaint, Lytle has been selling the devices for more than a decade and promoting them 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.
The FDA did issue an approval for QLaser to provide temporary relief of pain associated with osteoarthritis of the hand, but the device is not cleared to treat any other condition.
"Robert Lytle and his businesses ignored previous FDA warnings and continued to produce and distribute these devices in violation of federal law," Jan Welch, acting director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, said in a written statement. "The FDA will remain vigilant in protecting the health of the American public by ensuring that medical devices are shown to be safe and effective before being used by patients."
As a result of the injunction, Lytle and his businesses must cease directly or indirectly manufacturing, packing, labeling and/or distributing any device unless and until they obtain premarket approval or clearance from the FDA and comply with other terms of the injunction. The order also authorizes the FDA to inspect Lytle's businesses to ensure compliance, with costs for the inspection borne by Lytle. The court's order requires Lytle to pay restitution to QLaser customers for the profits he received from sales of his adulterated and misbranded devices.