Z-0444-2021Class II

SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt -

Name: Z-0444-2021 SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt -
Creator: Aesthetics Biomedical, Inc.
Published: 2020-03-13
License: https://open.fda.gov/license/

Aesthetics Biomedical, Inc. / initiated 2020-03-13 / Terminated

FDA source

Aesthetics Biomedical, Inc. began a recall of SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for... on 2020-03-13. FDA classified it as Class II and gives the reason as "A high frequency output (2 MHz) has not been cleared for distribution in the U.S". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0444-2021
Classification: Class II
Status: Terminated
Initiated: 2020-03-13
Posted: 2020-11-12
Terminated: 2021-09-01
Recalling firm: Aesthetics Biomedical, Inc.
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.
Product code: OUH Skin Resurfacing Rf Applicator
Reason for recall: A high frequency output (2 MHz) has not been cleared for distribution in the U.S.
FDA root 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 [email protected]. 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0444-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0444-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-18	2020-11-12

Product code OUH

K150409Class IIVIVACE Electrosurgical SystemSung Hwan E&B Co.,Ltd / cleared 2016-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)