Class 2 Device Recall Vivace Electrosurgical System

• Date Initiated by Firm: March 13, 2020
• Create Date: November 12, 2020
• Recall Status: Terminated on September 01, 2021
• Recall Number: Z-0444-2021
• Recall Event ID: 85891
• 510(K)Number: K150409
• Product Classification: Skin resurfacing rf applicator - Product Code OUH
• Product: SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
• Code Information: UDI Code: 08800017100326 All Lots/Serial Numbers: Serial Number range from 16019 to 20121. The Vivace Electrosurgical System is controlled by software system: VIVA-MA-01, V 1.0, Class B
• Recalling Firm/ Manufacturer: Aesthetics Biomedical, Inc.; 4602 N 16th St Ste 300; Phoenix AZ 85016-5162
• For Additional Information Contact: Sheldon Larson; 602-682-6424
• Manufacturer Reason for Recall: A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
• FDA Determined Cause: No Marketing Application
• Action: On 03/13/2020, the firm sent a customer notification letter via USPS informing customer that it was discovered that their RF Microneedling device contains the 2 MHz power level that has not been cleared for use within the United States. The Recalling Firm is offering the following offers: 1) Customers may have the 2MHz capability disabled until regulatory clearance is received. The Recalling Firm will arrange, at their expense, a convenient time with the customer's office to take this action. The planned field correction includes a replacement CPU to disable 2MHz functionality, but also provides the ability to reactivate the 2MHz with a password upon receipt of FDA clearance, which is currently underway. 2) Customers may voluntarily choose not to have a field correction completed and retain the current functionality of the Vivace device. The Recalling Firm is also asking that customers go to https://www.aestheticsbiomedical.com/request-for-service/ to respond with your decision either to: 1) Disable the 2MHz feature on your device, OR 2) Not to participate in the voluntary recall. The Recalling Firm will follow-up on all affirmative responses, to make arrangements with your practice, to execute the field correction. Our response time for field corrections will be contingent upon the status of COVID 19 and related travel authorities. Until we can arrange a correction we suggest you simply not use the 2MHz setting. If customers have further questions regarding the field correction, information on treatment protocols for use of the 1MHz setting, or have other questions on this topic please email the Recalling Firms standing device hotline at devicehotline@aestheticsbiomed.com. The Recalling Firm will return the email within 48 business hours. In addition, the Recalling Firm has posted the customer notification on its website: https://www.aestheticsbiomedical.com/press-releases/fda-cleared-vivace-remains-available/
• Quantity in Commerce: 623 units
• Distribution: U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = OUH and Original Applicant = Sung Hwan E&B Co.,Ltd