Importing unapproved medical devices is illegal. Trying to bribe a government official—equally bad.
Toan Le and Hang Ho, a married couple living in Burien, pleaded guilty today Seattle in connection with their attempt to import and use a cosmetic device that had not been approved for use in the U.S. by the Food and Drug Administration. Le pleaded guilty to providing an Illegal Gratuity to Public Official and Ho pleaded guilty to Introduction or Delivery for Introduction into Interstate Commerce of Adulterated Device.
According to the records in the case Le owns the Crystal Nails beauty salon in Burien, and Ho is an employee of the salon.
Ho admitted she attempted to import, into the United States, medical devices that had not been approved by the Food and Drug Administration in July. One of the devices was a “Skin Light Machine -- a laser type device for skin treatment. The device emits radiation at unknown levels.
When the FDA Consumer Safety Officer made an inspection, Le admits he offered first $500 and later $800 to allow the salon to keep the machine and other adulterated goods. On July 13, 2009, in Tukwila, Le delivered an envelope containing $800 to the Consumer Safety Officer. The officer was cooperating with law enforcement. Under the terms of the plea agreement, the pair forfeit the $800, as well as a variety of items from their salon which were adulterated or misbranded, including nine skin light machines, four hand held massagers, creams, bath salts and tweezers.
When sentenced Le faces up to two years in prison and Ho faces up to one year in prison.