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FDA 510(k)

CO2 Laser Therapy System (Model: LFS-D9U)

K-Number: K250998 · 2025-12-19

ApplicantSanhe Lefis Electronics Co., Ltd.
Decision Date2025-12-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 Laser Therapy System (Model: LFS-D9U) is the device name listed in this FDA 510(k) record. The listed applicant is Sanhe Lefis Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K250998. 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 CO2 Laser Therapy System (Model: LFS-D9U)?

CO2 Laser Therapy System (Model: LFS-D9U) is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Sanhe Lefis Electronics Co., Ltd.. The 510(k) number is K250998.

When did CO2 Laser Therapy System (Model: LFS-D9U) receive FDA 510(k) clearance?

CO2 Laser Therapy System (Model: LFS-D9U) received FDA 510(k) clearance on 2025-12-19, under 510(k) number K250998.

Who is the listed applicant for CO2 Laser Therapy System (Model: LFS-D9U)?

The FDA 510(k) record lists Sanhe Lefis Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Therapy System (Model: LFS-D9U)?

The FDA product code for CO2 Laser Therapy System (Model: LFS-D9U) is GEX. This falls under the Gastroenterology category.

Other records listing Sanhe Lefis Electronics Co., Ltd. as applicant

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.

K261204Intense Pulsed Light Therapy DeviceK252319Q-Switched Nd: YAG Laser machine (LFS-C13U)

Related Devices (Code: GEX)

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.

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 AmericaK261738Medical 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

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

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