Data / Medical devices / China / Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 7 510(k) clearances
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. is registered with the FDA (registration 3034630389) in Guangzhou Guangdong, China. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 6, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034630389
- Address
- Room 5002, 5003, 5004, A01 Building, No.74 Chuangyu Road Ningxi Street, Zengcheng District, Guangzhou Guangdong, China, 510000
- Owner or operator
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. (10092017)
- Roles
- Manufacturer
- First device listed
- November 25, 2024
- Registered through
- 2026
- Brand names listed
- Dornier HP100 Holmium Laser System (DORNIER HP100), Dornier HP120 Holmium Laser System (DORNIER HP120), Dornier HP140 Holmium Laser System (DORNIER HP140), Dornier HP150 Holmium Laser System (DORNIER HP150), Dornier HP90 Holmium Laser System (DORNIER HP90), Dornier TFL40 Thulium Fiber Laser System (DORNIER TFL40), Dornier TFL60 Thulium Fiber Laser System (DORNIER TFL60), EHL Probe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Cystometric, Hydraulic | FEN | 2 | Manufacturer | accessdata.fda.gov |
| Lithotriptor, Electro-Hydraulic | FFK | 2 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Uroflowmeter | EXY | 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 |
|---|---|---|---|---|---|---|
| March 6, 2026 | K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | GEX | Substantially Equivalent | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | accessdata.fda.gov |
| January 24, 2026 | K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | GEX | Substantially Equivalent | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | accessdata.fda.gov |
| November 24, 2025 | K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | GEX | Substantially Equivalent | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | accessdata.fda.gov |
| November 24, 2025 | K252771 | Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150) | GEX | Substantially Equivalent | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | accessdata.fda.gov |
| November 20, 2025 | K253007 | Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S) | GEX | Substantially Equivalent | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | accessdata.fda.gov |
| March 21, 2025 | K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | FFK | Substantially Equivalent | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | accessdata.fda.gov |
| March 21, 2025 | K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | FFK | Substantially Equivalent | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lithotriptor, Electro-Hydraulic
- All makers of Powered Laser Surgical Instrument
- All makers of Device, Cystometric, Hydraulic
- All makers of Uroflowmeter
Updated March 6, 2026. 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.