Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
FDA 510(k) K243430 · Shenzhen Aozemei Technology Co., Ltd.
510(k) numberK243430
Submission
- Device name
- Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
- Applicant
- Shenzhen Aozemei Technology Co., Ltd.
Shenzhen, CN - Received
- November 5, 2024
- Decision date
- December 19, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K253932 | FACEGYM Pro Device (HD-109)NFO · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 07/23/2026SE |
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| K252187 | Aura Glide (FC40)NFO · Traditional | Aura Medical, LLC | 12/23/2025SE |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…NFO · Traditional | Shenzhen Siken 3D Technology Development Co., Ltd. | 12/23/2025SE |
| K250618 | Medi Lift Essential Eye MaskNFO · Traditional | Ya-Man, Ltd. | 10/29/2025SE |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2)NFO · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 10/17/2025SE |
More from Shenzhen Qianyu Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)OHS · Traditional | 10/28/2024SE |
Questions and answers
When was Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) cleared by the FDA?
Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K243430) received a 510(k) decision of Substantially Equivalent on December 19, 2024, 44 days after the submission was received.
What is the product code of K243430?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.