Data / Medical devices / China / Shenzhen Aozemei Technology Co., Ltd.
Shenzhen Aozemei Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Aozemei Technology Co., Ltd. is registered with the FDA (registration 3033850491) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 19, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033850491
- Address
- 3/F, Building 9, Tianfu'an Industiral Park, lezhujiao, Huangmabu Community, Hangcheng Street, Baoan District, Shenzhen Guangdong, China, 518101
- Owner or operator
- Shenzhen Aozemei Technology Co., LTD. (10091745)
- Roles
- Manufacturer
- First device listed
- October 29, 2024
- Registered through
- 2026
- Brand names listed
- Clara Wand AM-8003, Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W), electric massage apparatus SYM-202501
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2024 | K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | NFO | Substantially Equivalent | Shenzhen Aozemei Technology Co., Ltd. | accessdata.fda.gov |
| October 28, 2024 | K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | OHS | Substantially Equivalent | Shenzhen Aozemei Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Massager, Therapeutic, Electric
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated December 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.