FDA 510(k)

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

K-Number: K252787 · 2025-11-24

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

Decision Date2025-11-24

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2025-11-24 under 510(k) number K252787. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)?

Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K252787.

When did Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) receive FDA 510(k) clearance?

Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) received FDA 510(k) clearance on 2025-11-24, under 510(k) number K252787.

Who is the listed applicant for Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)?

The FDA 510(k) record lists Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)?

The FDA product code for Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06721975Thulium Fiber Laser (TFL) vs Thulio Pulsed Thulium:YAG (p-Tm:YAG)RECRUITING NCT07087977HoYAG vs TFL in miniPCNL With ClearPetraRECRUITING

Other records listing Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. as applicant

K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)K253633Holmium Laser Therapeutic Apparatus (HZ-40)K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)K253007Laser 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)K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)K242888Electrohydraulic Lithotriptor (TCS-B3-II)

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Related Devices (Code: GEX)

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.