Medical Device Manufacturer · CN , Guangzhou

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

7 submissions · 7 cleared · Since 2025

7

Total

7

Cleared

0

Denied

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. — FDA 510(k) Submissions

Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. has submitted 7 FDA 510(k) premarket notifications since 2025, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Lithotriptor, Electro-hydraulic . Use the specialty filter in the sidebar to narrow results.

7 devices

1–7 of 7

Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)

K253951 · GEX Powered Laser Surgical... · General & Plastic Surgery

Holmium Laser Therapeutic Apparatus (HZ-40)

K253633 · GEX Powered Laser Surgical... · General & Plastic Surgery

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)

K252771 · GEX Powered Laser Surgical... · General & Plastic Surgery

Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)

K252787 · GEX Powered Laser Surgical... · General & Plastic Surgery

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)

K253007 · GEX Powered Laser Surgical... · General & Plastic Surgery

Electrohydraulic Lithotriptor (TCS-B3-II)

K242888 · FFK Lithotriptor,... · Gastroenterology & Urology

EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)

K243032 · FFK Lithotriptor,... · Gastroenterology & Urology

Data Source

FDA 510(k) public files . 174,402 total devices indexed.