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

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
7
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium LaseMarch 6, 2026
K253633Holmium Laser Therapeutic Apparatus (HZ-40)January 24, 2026
K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)November 24, 2025
K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (PotenNovember 24, 2025
K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); November 20, 2025
K242888Electrohydraulic Lithotriptor (TCS-B3-II)March 21, 2025
K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)March 21, 2025