Data / Medical devices / China / Jiangxi Medex Technology Co.,ltd
Jiangxi Medex Technology Co.,ltd: FDA-registered device maker in Xinfeng Jiangxi, China, 5 510(k) clearances
Jiangxi Medex Technology Co.,ltd is registered with the FDA (registration 3013529876) in Xinfeng Jiangxi, China. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated December 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013529876
- Address
- ChengXin Avenue,Xinfeng Industrial Area, Xinfeng Jiangxi, China, 330104
- Owner or operator
- JiangXi Medex Technology Co.,Ltd (10086146)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 18, 2022
- Registered through
- 2026
- Brand names listed
- Diode Laser System (LaserPro D980, LaserPro D810, Aurolance 980, Aurolance 810, Aurolance AM), LaserPro Diode Surgical Laser System, SACS,Independent Fiber Coolant System, SACSII, Independent Fiber Coolant System, SLT Select Fiber Delivery System and Contact Tips
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, 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 26, 2024 | K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM) | GEX | Substantially Equivalent | Jiangxi Medex Technology Co., Ltd. | accessdata.fda.gov |
| December 22, 2024 | K243121 | SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5; | GEX | Substantially Equivalent | Jiangxi Medex Technology Co., Ltd. | accessdata.fda.gov |
| October 28, 2008 | K082721 | LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS | GEX | Substantially Equivalent | Photo Medex, Inc. | accessdata.fda.gov |
| February 27, 1998 | K980156 | SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS | GEX | Substantially Equivalent | Surgical Laser Technologies, Inc. | accessdata.fda.gov |
| July 31, 1995 | K952754 | SACS, INDEPENDENT FIBER COOLANT SYSTEM | GEX | Substantially Equivalent | Surgical Laser Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 26, 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.