FDA WARNING_LETTER - BNB MEDICAL CO., LTD.

This FDA Warning Letter, dated April 19, 2011, addresses BNB Medical Co., Ltd. for marketing their BND Laser Hair Removal devices (Models W-808, CW-808, also known as Epila and Venus Laser Hair Removal devices) in the U.S. without marketing clearance or approval. The FDA determined these devices are adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) due to the absence of an approved premarket approval (PMA) application under section 515(a) or an investigational device exemption (IDE) under section 520(g). Additionally, the devices are misbranded under section 502(o) of the Act (21 U.S.C. 352(o)) because the firm failed to notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) (21 U.S.C. 360(k)). The firm's 510(k) application for Over-the-Counter use remains on hold, pending clinical data demonstrating safe and effective use by a lay person. BNB Medical Co. is instructed to immediately cease the sale and dissemination of promotional materials for these unapproved devices in the U.S. A written response detailing corrective actions, a prevention plan, and a timetable for implementation is required within fifteen working days. Failure to correct these violations may result in regulatory actions, including detention without physical examination, refusal of admission, impact on federal contracts, and denial of Certificates to Foreign Governments.