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510(k) Data Aggregation

    K Number
    K231153
    Device Name
    Neuhat Hair Growth System; ibeauty.com Laser Cap
    Manufacturer
    Nature Incredible Inc
    Date Cleared
    2023-06-23

    (60 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nature Incredible Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Neuhat Hair Growth System is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV. ibeauty.com Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.
    Device Description
    The System includes NEU180 and NEU300 two models. NEU180 consists of 50 laser diodes with wavelength at 655mm, power ≤5mW, and 130 red light diodes with wavelength at 650 nm, power ≤5mW. NEU300 consists of 100 laser diodes with wavelength at 655nm, power ≤5mW, and 200 red light diodes with wavelength at 650 nm, power ≤5mW. The System is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an adapter.
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    K Number
    K201854
    Device Name
    CAPOGEN Laser Cap
    Manufacturer
    Nature Incredible Inc
    Date Cleared
    2020-09-01

    (57 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nature Incredible Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CAPOGEN Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
    Device Description
    The CG-272 CAPOGEN Laser Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 272visible red light-emitting diodes at 650mm and 5mW each. The Cap is designed with an outer plastic cover and a protective inner (containing the electronics and laser array) and is powered by an included battery pack. The CG-148 CAPOGEN Laser Cap is exactly the same as the CG-272 with the exception of the number of diodes which is respective of model (148 diodes in CG-148).
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