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510(k) Data Aggregation

    K Number
    K253669

    Validate with FDA (Live)

    Device Name
    TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd.
    Date Cleared
    2026-01-23

    (63 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K242363,K213025
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device are indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.

    Device Description

    The Aduro Hair Growth (Model: M-130) is a device designed to be used with a baseball cap that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 660nm±10nm. The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

    The Trudermal Halo Hair growth system (Model: M-180A) is a device designed to be used with a baseball cap that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 660nm±10nm. The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.

    The Aduro Hair Growth (Model: M-300) is a device designed to be used with a baseball cap that emits led light and Laser with the intention to promote hair growth. The device provides distributed led and laser to the scalp at 650nm (±10nm). The device is designed as a head-mounted product, and it consists of the main unit, a controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 25-minute treatment is completed.

    AI/ML Overview

    N/A

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