Data / Medical devices / China / Shenzhen Yiguangnian Innovation Technology Co., Ltd.
Shenzhen Yiguangnian Innovation Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Yiguangnian Innovation Technology Co., Ltd. is registered with the FDA (registration 3013521677) in Shenzhen Guangdong, China. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 26, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013521677
- Address
- 504, Creative Building, Minle Science Park, Minzhi Street, Longhua District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen YiGuangNian Innovation Technology Co., Ltd. (10054588)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 5, 2017
- Registered through
- 2026
- Brand names listed
- BE LUCENT STELLAR XPRE170 XPRE137 XPRE067 XPRE153, Blackhead Remover XPRE129 XPRE143 XPRE133; XPRE027 XPRE202 XPRE037 XPRE113, Brush, Dermabrasion, Powered-Facial Cleansing, Brush:XPRE171; Heating Facial Cleansing Brush:XPRE158;, Cleaner, Denture, Mechanical - Electric Tooth Cleaner:XPRE151,XPRE152,XPRE174;, EMS and RF facial import and export massage instrument XPRE173 XPRE191;, Electric Tooth Cleaner XPRE176, Electric Tooth Cleaner XPRE178 Electric Ear Cleaner XPRE323 XPRE330, Electric Toothbrush XPRE012 XPRE132 XPRE144 XPRE145 XPRE035 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Grooming | ILW | 1 | Manufacturer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Manufacturer | accessdata.fda.gov |
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Cleaner, Denture, Mechanical | JER | 1 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | 1 | Manufacturer | accessdata.fda.gov |
| Led Light Source | NTN | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Thoracic | IPT | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | 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 |
|---|---|---|---|---|---|---|
| October 26, 2023 | K231595 | Electric Breast Pump | HGX | Substantially Equivalent | Shenzhen Changkun Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Brush, Dermabrasion, Powered
- All makers of Adaptor, Grooming
- All makers of Heat Source For Bleaching Teeth
- All makers of Toothbrush, Manual
- All makers of Led Light Source
- All makers of Unit, Oral Irrigation
Updated October 26, 2023. 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.