Data / Medical devices / China / Wuhan Guangdun Technology Co.,ltd
Wuhan Guangdun Technology Co.,ltd: FDA-registered device maker in WUHAN Hubei, China, 1 510(k) clearance
Wuhan Guangdun Technology Co.,ltd is registered with the FDA (registration 3012430589) in WUHAN Hubei, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 24, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012430589
- Address
- 3F, No. 303 Optical Chip Center, Optical Avenue, WUHAN Hubei, China, 430022
- Owner or operator
- WUHAN GUANGDUN TECHNOLOGY CO.,LTD (10085621)
- Roles
- Manufacturer
- First device listed
- January 11, 2023
- Registered through
- 2026
- Brand names listed
- 16 diodes laser therapy watch GD18M-2, 16 diodes laser therapy watch GD18M-2-1, 28 diodes laser therapy watch KJR-JGSG-A, 3 color handheld pain relief laser instrument GD-P-C, 312 diodes laser cap GD-JGM-A, 7 diodes laser therapy watch GD07-W-2, 96 diodes laser cap GD-JGM-B, Breast phototherapy apparatus KJR-RJG-D and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | 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 |
|---|---|---|---|---|---|---|
| January 24, 2025 | K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | NHN | Substantially Equivalent | Wuhan Guangdun Technology Co.,Ltd.. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- All makers of Lamp, Infrared, Therapeutic Heating
Updated January 24, 2025. 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.