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510(k) Data Aggregation

    K Number
    K213534
    Device Name
    PHantom Trilogy
    Manufacturer
    Resurgeonz LLC
    Date Cleared
    2022-03-11

    (126 days)

    Product Code
    OLI
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Resurgeonz LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Resurgeonz pHantom Trilogy(TM) is indicated for use as a non-surgical, non-invasive aesthetic treatment for the temporary reduction of the circumference of waist, hips, thighs through the process of disrupting adipocyte cells, within the fat layer, for the release of fat and lipids from the targeted cells.
    Device Description
    The Resurgeonz pHantom Trilogy™ is a non-surgical, non-invasive, fat reducing low level laser system using a combination of Red and Infrared light spectrums to propagate laser frequencies of 660nm, 808nm and 980nm into a patient's dermal and adipose tissues for the reduction of the measured circumference of the patients waist, hips, and thighs. The device features an LCD touchscreen. Mode of operation is continuous. Allows individual patient session controls of: treatment time, energy, pulse and delay. Emergency safety cut off switch. Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12. Paddles include built in air fan cooling. Combination of Coherent Frequencies of red and infrared: 26 diodes per big paddle, (13 red diodes at 660nm) and thirteen (13 infrared diodes) of the 13 infrared diodes, (6 diodes) are 808nm and (7 diodes) are 980nm. Two smaller paddles are available to swap out in place of two big paddles. The two smaller paddles only have 2 diodes each of red diodes at 660nm and are used for smaller hard to reach body areas. Power output or each diode is variable up to 72mW to per diode for all red and infrared diodes. The device does not have wireless and/or external wired communication. The device is powered by 120V, 60Hz. There is a side holder for paddles when not in use.
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