Data / Medical devices / United States / Aesthetics Biomedical Inc.
Aesthetics Biomedical Inc.: FDA-registered device maker in Phoenix, AZ, United States, 1 510(k) clearance
Aesthetics Biomedical Inc. is registered with the FDA (registration 3012204368) in Phoenix, AZ, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 16, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012204368
- Address
- 7227 N 16th St Ste 160, Phoenix, AZ, United States, 85020
- Owner or operator
- Aesthetics Biomedical Inc. (10051282)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 21, 2022
- Registered through
- 2026
- Brand names listed
- UltraVision RF Microneedling System, Vivace Ultra RF Microneedling System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Skin Resurfacing Rf Applicator | OUH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2022 | K221574 | LUDWIG Electrosurgical Device | GEI | Substantially Equivalent | Aesthetics Biomedical | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 13, 2020 | 85891 | Class II | Terminated | 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 wr | A high frequency output (2 MHz) has not been cleared for distribution in the U.S. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Skin Resurfacing Rf Applicator
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated October 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.