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510(k) Data Aggregation

    K Number
    K253279

    Validate with FDA (Live)

    Device Name
    Feather/numiere 05 06 07 (05)
    Manufacturer
    Heat IN A Click, LLC
    Date Cleared
    2025-12-24

    (86 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K223147,K242382
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage.

    Device Description

    Feather/ numiere 05 06 07 (Models: 05) is an over-the-counter light-emitting diode (LED) device that emits energy for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 830nm ±10nm wavelengths for the treatment of wrinkles on the neck and decolletage (upper chest). The device is designed in a flexible silicone panel that contains red (630nm±10nm) and near infrared (830nm±10nm) light-emitting diodes (LEDs). The device also contains a controller that controls the power on and off of the device, and regulates the intensity of the treatment by pressing buttons, and the controller

    AI/ML Overview

    N/A

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