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510(k) Data Aggregation

    K Number
    K243141
    Device Name
    Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)
    Manufacturer
    JiangXi Medex Technology Co., Ltd
    Date Cleared
    2024-12-26

    (87 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    JiangXi Medex Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, gentourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). Diode Laser System, (and the fiber delivery systems and accessories used to deliver laser energy), are in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: orthopedics.
    Device Description
    The Aurolance AM diode laser system consists of a unit, footswitch, power cord assembly, unit key, and protective eyewear. The Aurolance 980 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear. The Aurolance 810 diode laser system consists of a unit, footswtich, power cord assembly, unit key and protective eyewear. The LaserPro D980 diode laser system consists of a main unit, footswtich, power cord assembly, unit key, and protective eyewear. The LaserPro D810 diode laser system consists of a main unit, footswitch, power cord assembly, unit key and protective eyewear.
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