K243430 is an FDA 510(k) clearance for the Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W). This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Shenzhen Aozemei Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 19, 2024, 44 days after receiving the submission on November 5, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K243430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2024 |
| Decision Date | December 19, 2024 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NFO - Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |