Arasys Perfector Inc – FDA Warning Letter, Jun 28, 2010

The FDA issued a Warning Letter to Arasys Perfector, LLC, on June 28, 2010, for marketing the Arasys, Perfector, Ion Magnum, and iPico Perfector devices in the U.S. without marketing clearance or approval. The Office of Compliance in CDRH reviewed the firm's websites, http://www.arasysperfector.com and http://www.arasysperfectorusa.com.

The Arasys device was marketed with claims including muscle building, stamina increase, strength boost, detoxification, abs tightening, buttocks contouring, lymphatic drainage, skin tightening, breast enhancement, body revitalization, and cellulite reduction. The Perfector, Ion Magnum, and iPico Perfector were marketed with claims such as erasure of wrinkles, discolorations, acne, and scars.

These products are considered devices under Section 201(h) of the Federal Food, Drug, and Cosmetic Act. They are adulterated under section 501(f)(1)(B) of the Act because the firm lacks approved premarket approval (PMA) applications under section 515(a) or investigational device exemptions (IDE) under section 520(g). The devices are also misbranded under section 502(o) for failure to notify the agency of intent to introduce them into commercial distribution, as required by section 510(k).

The FDA requires prompt corrective action