# Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 7 (2025–2026): 7 510(k) clearances
- Product codes: GEX (5), FFK (2)
- 510(k) review time since 2016: median 83 days, against 90 for FDA's reviews in the same codes and years (5 of 5 faster)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Quanta System Spa: 4 (https://510kreport.com/company/quanta-system)
- Walz Elektronik GmbH: 2 (https://510kreport.com/company/walz-elektronik)
- Light Guide Optics International, Ltd.: 1 (https://510kreport.com/company/light-guide-optics-international)
- Asclepion Laser Technologies GmbH: 1 (https://510kreport.com/company/asclepion-laser-technologies)

## Recent decisions
- K253951: Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) (Mar 6, 2026)
- K253633: Holmium Laser Therapeutic Apparatus (HZ-40) (Jan 24, 2026)
- 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) (Nov 24, 2025)
- K252787: Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) (Nov 24, 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) (Nov 20, 2025)
- K243032: EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (Mar 21, 2025)
- K242888: Electrohydraulic Lithotriptor (TCS-B3-II) (Mar 21, 2025)

Source page: https://510kreport.com/company/guangzhou-potent-medical-equipment-joint-stock