Cutera, Inc.

CLOSEOUT LETTER Cutera, Inc. MARCS-CMS 639552 — March 09, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name David H. Mowry Recipient Title CEO Cutera, Inc. 3240 Bayshore Blvd. Brisbane , CA 94005 United States dmowry@cutera.com Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear David H. Mowry: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 639552, dated November 10, 2022). Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning 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/ 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 CC: John J. Smith, M.D., J.D. Hogan Lovells US LLP 555 Thirteenth Street, NW Washington, DC 20004 john.smith@hoganlovells.com Content current as of: 10/18/2024 Regulated Product(s) Medical Devices