Dr. Lytle and his business associations, Business Wizards, Inc., a/k/a QLaser Solutions Private Membership Association, and 2035, Inc., are involved in the manufacture and distribution of low-level laser devices called "QLasers." 13-MC-42 (Docket 2 at p. 2 ¶ 2). "Two QLaser models, the Q1000 and the 660 FlashProbe, received FDA clearance... on January 30, 2009, for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional." Id. at p. 3 ¶ 5. The FDA's inspections over a number of years revealed QLasers are distributed throughout the United States. Id. at p. 2 ¶ 3.