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    K Number
    K192275
    Device Name
    invisa-RED ELITE
    Manufacturer
    IR Technology LLC
    Date Cleared
    2020-08-19

    (363 days)

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

    IR Technology LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InvisaRED™ Technology ELITE is indicated for use as a non-invasive dermatological aesthetic treatment for the temporary reduction of the circumference of waist, hips, and thighs through the process of photobiomodulation, affecting adipocyte cells within the adipose layer for the release of lipids from these cells.
    Device Description
    Device console: - Electrical Power: 110v - Cooling: Air Cooled - Operation: LCD touch screen - Allows Control of Individual Patient Session Protocol (Time, Energy, Pulse, Delay) - Integrated Device Power-On Self Test - Emergency Safety cut off switch - Treatment applicators (multi diode paddles) connected to the device console can number 8,10, or 12 - Paddle Cooling: Air cooled - . Dual Coherent Frequencies: Thirteen (13) 680nm and thirteen (13) 980nm laser diodes on each paddle - Concurrent Laser Diode Mode of Operation: pulsed or continuous output - . Power output: Variable up to 200mw per diode for both 680nm and 980mm wavelengths
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