Advanced Photonic Systems, LLC – FDA Warning Letter, Mar 27, 2013

On March 27, 2013, the FDA inspected Advanced Photonic Systems, Inc. in Orlando, Florida, and reviewed information for their UltraSlim and Luxurian 150 lighting systems, including their website and user manuals. The FDA determined these products are devices under section 201(h) of the Act, intended for uses such as improving the appearance of fat deposits, cellulite, fine lines, wrinkles, skin tone, and blemishes, and assisting with weight loss.

The firm is marketing these devices in the U.S. without premarket clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. Consequently, the UltraSlim and Luxurian 150 lighting systems are adulterated under section 501(f)(1)(B) of the Act because there is no approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). They are also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce the devices into commercial distribution, as required by section 510(k).

Advanced Photonic Systems is required to immediately cease activities resulting in the misbranding or adulteration of these devices, including commercial distribution for the stated uses. The firm must provide a written response within fifteen business days detailing specific corrective actions, a plan to prevent recurrence, and a timetable for implementation. Failure to comply may result in regulatory actions such as