Effective on October 24th 2014, The FDA placed an injuction on the company that is associated with this product. Here is some of the verbiage from the Federal Government's injuction.
1. This statutory injunction proceeding is brought under the Federal Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. § 3 32(a), to enjoin 2035, Inc, a corporation, and Dr. Robert L. Lytle, an individual Who also goes by the name Dr. Larry Lytle and does business as 2035 Private Membership Association (“2035 PMA”) and QLasers Private Membership Association (hereafter collectively, “Defendants”), from violating:
A. 21 U.S.CI. § 331(a), by introducing or delivering for introduction into interstate commerce, and/or causing the introduction or delivery for introduction into interstate commerce of, articles of device, as de?ned by 21 U.S.C. § 321(h), that are adulterated Within the meaning of 21 U.S.C. § 351(f)(1)(B), in that they are class III devices pursuant to 21 U.S.C. 360c (f), and they are not the subjects of approved applications for premarket approval as required by 21‘ U.S.C. § 360e(a), nor are they the subjects Of an effective investigational device - exemption under 21 U.S.C. 360j(g); and;
Here is the link to the PDF for the complete injunction.