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FDA 510(k)

Q-Switched Nd: YAG Laser machine (LFS-C13U)

K-Number: K252319 · 2025-10-20

ApplicantSanhe Lefis Electronics Co., Ltd.
Decision Date2025-10-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q-Switched Nd: YAG Laser machine (LFS-C13U) is a medical device manufactured by Sanhe Lefis Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-10-20 under approval number K252319. 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 Q-Switched Nd: YAG Laser machine (LFS-C13U)?

Q-Switched Nd: YAG Laser machine (LFS-C13U) is a medical device that received FDA 510(k) clearance on 2025-10-20. It is manufactured by Sanhe Lefis Electronics Co., Ltd.. The 510(k) number is K252319.

When was Q-Switched Nd: YAG Laser machine (LFS-C13U) approved by the FDA?

Q-Switched Nd: YAG Laser machine (LFS-C13U) received FDA 510(k) clearance on 2025-10-20, under approval number K252319.

What company makes Q-Switched Nd: YAG Laser machine (LFS-C13U)?

Q-Switched Nd: YAG Laser machine (LFS-C13U) is manufactured by Sanhe Lefis Electronics Co., Ltd..

What is the FDA product code for Q-Switched Nd: YAG Laser machine (LFS-C13U)?

The FDA product code for Q-Switched Nd: YAG Laser machine (LFS-C13U) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

Other Devices by Sanhe Lefis Electronics Co., Ltd.

K250998CO2 Laser Therapy System (Model: LFS-D9U)

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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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