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510(k) Data Aggregation

    K Number
    K252187

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2025-12-23

    (162 days)

    Product Code
    Regulation Number
    882.5890
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Aura Glide is an over-the-counter handheld device for aesthetic purposes.
    (1) The microcurrent mode is indicated for facial stimulation.
    (2) The LED mode is intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate inflammatory acne (blue light).

    Device Description

    Aura Glide is a lemon shaped handheld device that consists of:

    • A main control body that is programmed with preset treatment modes depending on the application at the time of use.
    • Two (2) essential attachments that are detachable. Each attachment is specifically designed to sit securely on the main body to ensure proper functionality and stability during use.
      • LED (Light Emitting Diode) Attachment – intended for the treatment of periorbital wrinkles (red light) and for the treatment of mild to moderate acne (blue light).
      • Microcurrent Attachment – indicated for facial stimulation. Microcurrent can be delivered with three (3) levels of intensity; L1 (Gentle; Default), L2 (Standard), and L3 (Strong) depending on user preference.
    • Conductive gel (Glide On Primer gel) must be applied prior to starting microcurrent treatment. It enhances conductivity ensuring safe and effective microcurrent treatment.
    • The Aura Glide is equipped with a USB-C charging port located on the bottom of the device and an internal rechargeable battery. A USB-C charging cable is provided with every device.

    The Aura Glide is an over-the-counter cosmetic device for home use.

    AI/ML Overview

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