Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
FDA 510(k) clearance K243430 · decided 2024-12-19
Clearance details
- K-number
- K243430
- 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
- 2024-11-05
- Decision date
- 2024-12-19
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- NFO
- Device class
- 2
- Regulation number
- 882.5890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.