Product areas
FDA product code distribution
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Country / region:China (CN)
510(k) submissions
5
Latest clearance
2026-03-06
Product codes
1
GEX
Cited as predicate
0
510(k) submissions
5 total
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K253951 | Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) | GEX | Class 2 | 2026-03-06 |
| K253633 | Holmium Laser Therapeutic Apparatus (HZ-40) | GEX | Class 2 | 2026-01-24 |
| K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | GEX | Class 2 | 2025-11-24 |
| 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 | Class 2 | 2025-11-24 |
| 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 | Class 2 | 2025-11-20 |
Company profile
- Canonical name
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Country
- China(CN)
Cited predicates
7Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. as a predicate