Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
FDA 510(k) clearance K241718 · decided 2024-10-28
Clearance details
- K-number
- K241718
- Device name
- Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
- Applicant
- Shenzhen Aozemei Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-14
- Decision date
- 2024-10-28
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- OHS
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.