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510(k) Data Aggregation

    K Number
    K253135

    Validate with FDA (Live)

    Device Name
    LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.)
    Manufacturer
    Dongguan Yijiaming Technology Co., Ltd.
    Date Cleared
    2025-12-23

    (89 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K252264,K230042
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For model:HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HGMZ-2W-G1V1,HGMZ-2W-G2V1
    The LED LIGHT THERAPY MASK is an Over-the-Counter (OTC) light based device
    Red light: Treatment of full- face wrinkles (only model HHGMZ-2W-G1V1, HGMZ-2W-G2V1).
    Blue light: Treatment of mild to moderate inflammatory acne. (only suitable model HLGMZ-3W-G1V1 and HLGMZ-3W-G2V1)
    Mixed light(Red+NIR light): Treatment of full face wrinkles (Model: HLGMZ-3W-G1V1, HLGMZ-3W-G2V1)

    For model:HLG-GJXJ-G1V1,MRD-GJXJ-G1V1
    The Led Light Therapy for Neck is an Over-the-Counter (OTC) light based device
    Red light: Treatment of neck wrinkles (Model: MRD-GJXJ-G1V1)
    Mixed light(Red+NIR light): Treatment of neck wrinkles (Model: HLG-GJXJ-G1V1)

    Device Description

    The LED Light Therapy Device is a home-use phototherapy device designed to provide targeted treatment for skin conditions using specific wavelengths of light. The device incorporates advanced LED technology to deliver red (660nm), near-infrared (850nm), and blue (415nm) light. This combination of wavelengths is intended to address two primary skin concerns: full-face wrinkles and mild to moderate inflammatory acne.

    Significant Physical and Performance Characteristics:
    • Design: The device features a lightweight and ergonomic design, making it comfortable to wear. It includes adjustable head straps and eye pads to ensure a secure and comfortable fit during treatment.

    • Materials: The device is constructed from high-quality, durable materials, including nylon fabric and clear silicone, ensuring safety and comfort during use.

    • Performance: The device includes 74 LEDs, each with a 3-in-1 chip structure (660nm + 415nm + 850nm), providing dual-mode functionality (Red and Blue Light or Red+IR and Blue light). It offers three adjustable brightness levels (L1-L5) and three timing options (10, 15, 20 minutes) to customize the treatment according to user needs.

    • Power Supply: The device is powered by a 5V 2A adapter, with an input voltage range of 100-240V 50/60Hz, ensuring compatibility with various power sources worldwide.

    AI/ML Overview

    N/A

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