Data / Medical devices / China / Hebei Zhemai Technology Co.,ltd
Hebei Zhemai Technology Co.,ltd: FDA-registered device maker in Sanhe Hebei, China, 3 510(k) clearances
Hebei Zhemai Technology Co.,ltd is registered with the FDA (registration 3032147807) in Sanhe Hebei, China. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3032147807
- Address
- On the second floor of Building 14 #1-101,Phase l, Zhongnan High tech,Yanjiao Science and Technology Innovation Smart Valley Industrial Park, Yanjiao High tech Zone, Sanhe Hebei, China, 065201
- Owner or operator
- Hebei Zhemai Technology Co.,Ltd (10091104)
- Roles
- Manufacturer
- First device listed
- July 2, 2024
- Registered through
- 2026
- Brand names listed
- BUBBL, Diode laser therapy device(FD-L01), Intense pulsed light therapy device(FI-L06), Q-Switched Nd:Yag laser(FQ-L08), Tri-Pulse
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 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 1, 2023 | K232708 | Intense pulsed light therapy device | ONF | Substantially Equivalent | Hebei Zhemai Technology Co., Ltd. | accessdata.fda.gov |
| November 30, 2023 | K232716 | Q-Switched Nd:Yag laser | GEX | Substantially Equivalent | Hebei Zhemai Technology Co., Ltd. | accessdata.fda.gov |
| November 30, 2023 | K232709 | Diode laser therapy device | GEX | Substantially Equivalent | Hebei Zhemai Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated December 1, 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.