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510(k) Data Aggregation

    K Number
    K243852
    Device Name
    Elfor-L
    Manufacturer
    Elfi-Tech Ltd.
    Date Cleared
    2025-04-14

    (119 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Why did this record match?
    Applicant Name (Manufacturer) :

    Elfi-Tech Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elfor L is intended for measuring micro-vascular perfusion in skin and muscle in humans. It is intended to be used for clinical research applications and pre clinical research applications.
    Device Description
    The Elfor-L device is making use of Miniaturized Dynamic Light Scattering (mDLS) technology to non-invasively measure micro-vascular perfusion in the skin. The device is comprised of sensor and signal processing station. The device uses Vertical-Cavity Surface-Emitting Lasers (VCSEL) as the light source and two photodetectors for detection. The Elfor-L design incorporates three major components: 1. Sensor - the sensor as its predicate includes a laser light source and two photo sensitive elements. The sensor transfers analog signal to the control unit. 2. Control unit - the control unit is connected to the sensor by cable and includes the control circuit for the sensor, microcontroller and communication interface for the PC. 3. Dedicated software that processes, displays and record data on the computer. The computer is not part of the system.
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