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510(k) Data Aggregation

    K Number
    K251903

    Validate with FDA (Live)

    Date Cleared
    2026-02-19

    (244 days)

    Product Code
    Regulation Number
    890.5500
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Erchonia® DPN Laser is indicated while using the red and violet diode simultaneously for prescription home use as an adjunctive treatment in providing temporary relief of diabetic peripheral neuropathy foot pain.

    Device Description

    The Erchonia® DPN Laser (Model# EVRL) is a handheld, self-contained, lightweight, battery-operated low-level laser therapy (LLLT) device designed for use in prescription home environments. It delivers non-thermal, non-invasive laser light at specific wavelengths to provide a therapeutic benefit without generating heat. The DPN Laser builds upon the red and violet laser technology of the predicate Erchonia® EVRL (K191257), which is indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin under product code NHN.

    The DPN Laser device utilizes two semiconductor laser diodes that emit visible red (640 nm ± 10 nm) and violet (405 nm ± 10 nm) light, each delivering 7.5 mW.

    The DPN Laser incorporates a single, non-adjustable neuropathy treatment protocol, which is pre-programmed into the device and not accessible for modification by the end user. There is no interface available that permits alteration of the laser output power or wavelength, ensuring consistent and controlled therapeutic delivery.

    The laser is powered by an internal rechargeable battery. Recharging is accomplished via a separate inductive charging base, which operates using an external medical-grade power supply compatible with 120V/60Hz or 220V/50Hz AC mains power. The DPN Laser system features a user-friendly touchscreen interface that functions as both a display and control panel. The touchscreen communicates with the internal printed circuit board (PCB) to initiate or pause laser energy delivery. Detailed operating instructions for touchscreen use and treatment application are provided in the Erchonia DPN Laser Proper Use Reference guide.

    The associated accessories include:

    • (1) DPN Laser (no assembly required)
    • (1) Proper Use Reference Guide
    • (1) Laser Safety Goggles
    • (1) Charger Base
    • (1) Charger Base Power Supply Connector
    AI/ML Overview

    N/A

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