FDA WARNING_LETTER - 2035, Inc. - May 27, 2010

The FDA issued a Warning Letter to 2035, Inc. and QLaser Healing Light LP following a May 25-27, 2010, inspection in Rapid City, South Dakota. The firms were found to be marketing the Q10 Laser and 808 Enhancer Probe without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. These devices are adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE), and misbranded under section 502(o) for not submitting a 510(k) notification.

Additionally, the Q1000 Laser and 660 Enhancer Probe (QLaser System), cleared for temporary pain relief from osteoarthritis of the hand, were promoted with unapproved claims on websites and in brochures. These claims, including uses for healing wounds, re-energizing cells, treating various pains, inflammation, and balancing the autonomic nervous system, constitute a major change in intended use requiring a new 510(k) notification. This renders the devices adulterated and misbranded.

The FDA requested immediate cessation of marketing the Q1000 Laser and 660 Enhancer Probe for unapproved uses. The firms must respond within 15 working days with corrective actions, including documentation and a timetable, to address all violations and