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FDA 510(k)

Fractional CO2 Laser Therapy System (EXFU CO2)

K-Number: K242183 · 2024-10-23

ApplicantWeifang Mingliang Electronics Co., Ltd.
Decision Date2024-10-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fractional CO2 Laser Therapy System (EXFU CO2) is a medical device manufactured by Weifang Mingliang Electronics Co., Ltd.. It received FDA 510(k) clearance on 2024-10-23 under approval number K242183. 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 Fractional CO2 Laser Therapy System (EXFU CO2)?

Fractional CO2 Laser Therapy System (EXFU CO2) is a medical device that received FDA 510(k) clearance on 2024-10-23. It is manufactured by Weifang Mingliang Electronics Co., Ltd.. The 510(k) number is K242183.

When was Fractional CO2 Laser Therapy System (EXFU CO2) approved by the FDA?

Fractional CO2 Laser Therapy System (EXFU CO2) received FDA 510(k) clearance on 2024-10-23, under approval number K242183.

What company makes Fractional CO2 Laser Therapy System (EXFU CO2)?

Fractional CO2 Laser Therapy System (EXFU CO2) is manufactured by Weifang Mingliang Electronics Co., Ltd..

What is the FDA product code for Fractional CO2 Laser Therapy System (EXFU CO2)?

The FDA product code for Fractional CO2 Laser Therapy System (EXFU CO2) is GEX. This falls under the Gastroenterology category.

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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 Weifang Mingliang Electronics Co., Ltd.

K200525Medical Diode Laser Hair Removal System K260307Diode Laser Therapy Systems (V19)

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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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