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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 a medical device manufactured by Sanhe Lefis Electronics Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval 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. It is manufactured by Sanhe Lefis Electronics Co., Ltd.. The 510(k) number is K250998.

When was CO2 Laser Therapy System (Model: LFS-D9U) approved by the FDA?

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

What company makes CO2 Laser Therapy System (Model: LFS-D9U)?

CO2 Laser Therapy System (Model: LFS-D9U) is manufactured by Sanhe Lefis Electronics Co., Ltd..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40942702 Digital Cardiovascular Twins, AI Agents, and Sensor Data: A Narrative Review from System Architecture to Proactive Heart Health. Sensors (Basel, Switzerland) (2025) PMID: 40624966 Peptide-Enhanced Bioactive Hydrogel Combined with Photodynamic-Phage Synergistic Antibacterial Therapy System Accelerates Infected Wound Healing. Advanced healthcare materials (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Sanhe Lefis Electronics Co., Ltd.

K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)

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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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