K243430
- 510(k) number
- K243430
- Device name
- Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
- Applicant
- Shenzhen Aozemei Technology Co., Ltd. CN
- Product code
- NFO — Stimulator, Transcutaneous Electrical, Aesthetic Pur
- Decision date
- 2024-12-19
- Date received
- 2024-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243430.pdf
Official FDA record: K243430
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.