Opgal Optronic Industries Ltd.

CLOSEOUT LETTER Opgal Optronic Industries Ltd. MARCS-CMS 613562 — July 20, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Eran Bluestein Recipient Title Director of Business Development Opgal Optronic Industries Ltd. PO Box 462, Industrial Area 5 Karmiel 2161401 Israel eran.b@opgal.com Issuing Office: Center for Devices and Radiological Health United States Dear Eran Bluestein: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 613562, dated March 4, 2021). Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. 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 in the future. Sincerely yours, /S/ Courtney H. Lias, Ph.D. Office Director OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Content current as of: 07/25/2023 Regulated Product(s) Medical Devices