Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Guangzhou Guangdong, CN
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. appears in FDA device records in Guangzhou Guangdong, CN. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. between 2025 and 2026. The busiest year on record is 2025, with 5. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2025 | 5 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | GEX | Substantially Equivalent | |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | GEX | Substantially Equivalent | |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | GEX | Substantially Equivalent | |
| 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 | |
| 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 | |
| K243032 | EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) | FFK | Substantially Equivalent | |
| K242888 | Electrohydraulic Lithotriptor (TCS-B3-II) | FFK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3034630389 | 3034630389 | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | Room 5002, 5003, 5004, A01 Building, No.74 Chuangyu Road, Guangzhou Guangdong 510000 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain