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510(k) Data Aggregation

    K Number
    K180460
    Device Name
    Theradome LH40
    Manufacturer
    Theradome, Inc.
    Date Cleared
    2018-05-18

    (87 days)

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

    Theradome, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Theradome LH40 (Theragrow) is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton of IIa to 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; both with Fitzpatrick Skin Types I to IV.
    Device Description
    The Theradome LH40 (Theragrow) laser helmet is a low level laser therapy (LLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles to promote hair growth via photobiostimulation of the scalp. The lasers are contained inside a lightweight, one-size-fits-all helmet. The Theradome LH40 device utilizes 40 laser diodes to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment is complete.
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    K Number
    K161046
    Device Name
    Laser Helmet LH40-EVO
    Manufacturer
    Theradome, Inc
    Date Cleared
    2016-05-12

    (29 days)

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

    Theradome, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Theradome Laser Helmet LH40 EVO is an over the counter (OTC) device indicated to treat androgenetic alopecia, to promote hair growth in female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to IV.
    Device Description
    Similar to the Theradome LH80 PRO, the iGrow-II and the HairMax LaserComb 41, the modified Theradome LH40 EVO laser helmet is a low level laser therapy (LLLT) device containing red, visible light diode lasers operating at 678 nanometers, designed to deliver non-thermal energy to the hair follicles used to promote hair growth via photobiostimulation of the scalp. The lasers are contained inside a lightweight, one-sizefits-all helmet. The LH40 EVO utilizes 40 laser diodes to deliver laser stimulation to the entire scalp for hands-free operation during treatment. The device is one-button operated, and has an audible timer that automatically turns the lasers off after the 20 minute treatment completes.
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