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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 a medical device manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2025-11-24 under approval 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. It is manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K252787.

When was Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) approved by the FDA?

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

What company makes 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 manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd..

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.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.

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) K242888Electrohydraulic Lithotriptor (TCS-B3-II) K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E) K253633Holmium Laser Therapeutic Apparatus (HZ-40)

View all 7 devices →

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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.

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