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510(k) Data Aggregation

    K Number
    K241057
    Device Name
    Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
    Manufacturer
    Wuhan Guangdun Technology Co.,Ltd.
    Date Cleared
    2025-01-24

    (281 days)

    Product Code
    NHN
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Wuhan Guangdun Technology Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GD-P-E Enhanced Handheld Pain Relief Laser Instrument generally indicated: - adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin; - adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS)
    Device Description
    The GD-P-E Enhanced Handheld Pain Relief Laser Instrument consists of a LCD, button, battery, power charger jack. Accessories include a power cords, a power adapter. It is a handheld, non-invasive, non-heating infrared cold laser instrument designed to be used as an adjunct treatment for managing the temporary relief of pain associated with Carpal Tunnel Syndrome. A key feature of the device is its ability to produce multiple laser wavelengths (808nm and 650nm). A key feature of the device is its ability to emit dual laser wavelengths (808nm and 650nm), providing targeted low-level light therapy to the affected area. This "cold" laser therapy enables body tissue to absorb the light, facilitating a temporary reaction within the cells that promotes minor pain relief.
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