FDA WARNING_LETTER - Lightwave Technologies, LLC - September 21, 2012

On January 3, 2013, the FDA issued a Warning Letter to Lightwave Technologies, LLC following a September 17-21, 2012 inspection in Phoenix, Arizona. The firm manufactures Lightwave Deluxe, Professional, and Elite L.E.D. devices, which are classified as medical devices. The inspection revealed significant violations. Firstly, the Lightwave devices are adulterated under Section 501(f)(1)(B) of the Act because the firm lacks an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) for their current marketing claims. The firm is marketing these devices for unapproved uses such as stretch marks, cellulite, and hair loss, which extend beyond their 510(k) cleared indications for dermatological conditions, acne, wrinkles, and pain relief. Secondly, the devices are misbranded under Section 502(o) of the Act and 21 CFR 807.81(a)(3)(ii) due to the firm's failure to notify the FDA of its intent to introduce the devices into commercial distribution. Thirdly, all devices are misbranded under Section 502(o) because the firm failed to fulfill annual establishment registration and device listing requirements under Section 510 of the Act for 2011 and as of December 21, 2012. Lightwave Technologies must take prompt action to correct these violations and notify the FDA in writing within fifteen business days, detailing corrective actions, prevention plans, and a timetable if corrections extend beyond this period. Failure to comply could lead to regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts. The letter also noted that these violations might indicate broader issues within the firm's manufacturing and quality management systems.