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FDA 510(k)

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)

K-Number: K253007 · 2025-11-20

ApplicantGuangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
Decision Date2025-11-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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) is a medical device manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. It received FDA 510(k) clearance on 2025-11-20 under approval number K253007. 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 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)?

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) is a medical device that received FDA 510(k) clearance on 2025-11-20. It is manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. The 510(k) number is K253007.

When was 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) approved by the FDA?

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) received FDA 510(k) clearance on 2025-11-20, under approval number K253007.

What company makes 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)?

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) is manufactured by Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd..

What is the FDA product code for 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)?

The FDA product code for 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) is GEX. This falls under the Gastroenterology category.

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

K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) 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) 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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