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510(k) Data Aggregation

    K Number
    K221873
    Device Name
    NeoGen PSR System
    Manufacturer
    Date Cleared
    2023-01-12

    (198 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Energist Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    When used with the 5mm nozzle the NeoGen PSR System is intended for treatment of the following dermatological conditions : - · Treatment of wrinkles and rhytids - · Superficial skin lesions - · Actinic Keratosis - Viral Papillomata - · Seborrheic Keratosis - · Acne Scars When used with the 25mm nozzle, the NeoGen PSR System is intended for coagulation of tissue in dermatological procedures.
    Device Description
    The system comprises the following major elements: - . The Energist NeoGen PSR generator. This incorporates a source of Ultra High Frequency (UHF) energy and the gas control system required to support creation of nitrogen plasma; - . A Footswitch – single pedal type for activation of the plasma output. - . A handpiece that connects to the generator via an umbilical, which incorporates electrical and gas connections. The handpiece incorporates a finger-operated button switch that can be used to activate the plasma as an alternative to the footswitch. - . A Procedure Pack, comprising one or more limited life disposable tips (nozzles) through which the plasma is delivered. These are a snap fit to the distal end of the handpiece; - A gas supply system - principally a nitrogen gas cylinder and a regulator assembly; - . A bespoke trolley which provides a secure, mobile platform for the generator, handpiece, gas cylinder (plus a spare cylinder) and gas regulator assembly.
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