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510(k) Data Aggregation

    K Number
    K260202

    Validate with FDA (Live)

    Device Name
    LED Light Therapy Masks (LumiLips FAC07NA)
    Manufacturer
    Guangdong Newdermo Biotech Co., Ltd.
    Date Cleared
    2026-03-23

    (59 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K172662,K213024
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LED Light Therapy Mask is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.

    Device Description

    LED Light Therapy Mask is a home use device. LED Light Therapy Mask - LumiLips FAC07NA uses Light Emitting Diode (LED) energy to treatment of fine lines and wrinkles and increase in circulation within the perioral region. There are 4 kinds of light which include Red light (wavelength 630nm), Dark red light (wavelength 660nm), Near-Infrared light (wavelength 880nm), Amber light (wavelength 605nm).

    There is only one model of LED Light Therapy Mask: LumiLips FAC07NA. The product consists of LED lip mask, Mouthpiece, charging cable. The mouthpiece can be removable.

    The application area of LumiLips FAC07NA is the lips and surrounding area.

    AI/ML Overview

    N/A

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