Neo Vision Co Ltd

CLOSEOUT LETTER Neo Vision Co Ltd MARCS-CMS 506797 — February 20, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Kyung-Hwa Kim Recipient Title President Neo Vision Co Ltd 129-1 Donghwagongdan-Ro Munmak-Eup Wonju-si Gangwon-do 26361 South Korea Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mr. Kim: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our letter (CMS# 506797) dated September 14, 2016. Based on our evaluation, it appears that you have addressed the violations contained in the letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ CAPT Raquel Peat, PhD, MPH Director Division of Premarket and Labeling Compliance Office of Compliance Center for Devices and Radiological Health Cc: US Agent Kelly Kim Kelly Medical Consulting 27001 La Paz Road, Suite# 314 Mission Viejo, CA 92691 Content current as of: 02/28/2018