Class II — Aesthetics Biomedical, Inc.
| Recalling firm | Aesthetics Biomedical Inc. |
|---|---|
| Registered facility | AESTHETICS BIOMEDICAL INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A high frequency output (2 MHz) has not been cleared for distribution in the U.S. |
| 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. |
| Quantity | 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. |
| Initiated | 2020-03-13 |
| Classified | 2020-11-12 |
| Terminated | 2021-09-01 |
| Recall number | Z-0444-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Aesthetics Biomedical, Inc. (Z-0444-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85891/
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