510(k) K243430
K243430 is an FDA 510(k) premarket notification submitted by Shenzhen Aozemei Technology Co., Ltd. for the device "Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)". The FDA issued a decision of Substantially Equivalent on December 19, 2024. The device falls under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes), a Class II device regulated under 21 CFR 882.5890. Shenzhen Aozemei Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2024
- Date Received
- November 5, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type