FDA cleared the Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) from Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. on Nov 24, 2025 under K252787, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Sep 2, 2025. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).
Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K253951 (Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)), K253633 (Holmium Laser Therapeutic Apparatus (HZ-40)), 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)), 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)).