Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K173843
    Device Name
    illumiflow 148 Laser Cap
    Manufacturer
    EGlobal, LLC
    Date Cleared
    2018-01-26

    (39 days)

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

    EGlobal, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The illumiflow 148 Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of Ila to V or females with androgenic alopecia who have Ludwig-Savin Hair Classifications of I-II and both with Fitzpatrick Skin Phototypes I to IV
    Device Description
    Similar to the original illumiflow 272 Laser Cap and the predicate LaserCap 120, the modified illumiflow 148 Laser Cap is a low-level laser therapy (LLLT) helmet device containing red. visible light diode lasers operating at 650 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp. The illumiflow 148 Laser Cap utilizes 148 laser diodes to deliver laser stimulation to the scalp. The device is operated via a single button on the battery pack, and has an audible timer that automatically turns the lasers off after a 30-minute treatment session.
    Ask a Question
    K Number
    K162071
    Device Name
    IllumiFlow Laser Cap
    Manufacturer
    EGLOBAL, LLC
    Date Cleared
    2017-02-24

    (212 days)

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

    EGLOBAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The illumiflow Laser Cap is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa to V or females with androgenic alopecia who have Ludwig-Savin Classifications of I – II and both with Fitzpatrick Skin Phototypes I to IV.
    Device Description
    The illumiflow 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 272 visible red light-emitting diodes at 650-nm and 5mW each. The cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included Battery Pack.
    Ask a Question

    Page 1 of 1