FDA WARNING_LETTER - Quanta Aesthetic Lasers USA, LLC

On June 16, 2012, the FDA issued a Warning Letter to Quanta Aesthetic Lasers USA, LLC, regarding their Quanta System Q-Plus T device. The FDA's review of the firm's website, www.quantausa.com, revealed that the device was being marketed for unapproved indications and with unapproved modifications.

The Quanta System Q-Plus T (K073549) was cleared for specific indications including treatment of vascular lesions, pigmented lesions, hair and tattoo removal, and soft tissue incision/excision/ablation/vaporization using Nd:YAG (1064nm, 532nm) and Ruby (694nm) lasers.

However, the firm's website promoted the device for "skin rejuvenation," "skin lifting," "skin tightening/smoothness," "acne treatments," "anti-aging," "firming," and "treatment of scars and keloids." These claims represent a major change in intended use, potentially affecting safety and effectiveness. Consequently, the device is adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) for lacking required premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) (21 U