510(k) K241718
K241718 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 October 28, 2024. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810. Shenzhen Aozemei Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 2024
- Date Received
- June 14, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over The Counter Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.