FDA
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.
A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
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/