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510(k) Data Aggregation

    K Number
    K171775
    Device Name
    Theradome LH80 PRO
    Manufacturer
    Theradome Inc.
    Date Cleared
    2018-01-09

    (209 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 LH80 PRO is an over-the-counter (OTC) therapeutic device intended to treat Androgenetic Alopecia and promote hair growth in males who have Norwood-Hamilton Classifications 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 LH80 PRO for men and women is a low level coherent light therapy (LLLT) device utilised to promote hair growth. The coherent lights are contained inside a lightweight, one-size fits all helmet. The Theradome LH80 PRO uses 80 coherent light diodes in the helmet to deliver coherent light stimulation to the entire scalp for hands-free operation during treatment. An audible timer automatically turns the coherent lights off after the 20 minutes treatment is completed. This coherent light helmet is not constructed to be a safety helmet.
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    K Number
    K122950
    Device Name
    LASER HELMET
    Manufacturer
    THERADOME INC.
    Date Cleared
    2013-06-14

    (262 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 LH80 PRO is an over the counter (OTC)device indicated to treat androgenic alopecia, to Promote hair growth in females with female pattern hair loss (FPHL) on the Ludwig and Savin Hair Loss Scale I-II, Fitzpatrick Skin-Types I to IV:
    Device Description
    The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes 80 laser diodes in the helmet 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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    K Number
    K113097
    Device Name
    LASER HELMET
    Manufacturer
    THERADOME INC.
    Date Cleared
    2012-03-02

    (135 days)

    Product Code
    OAP, NHN, REQ
    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 LH80 PRO is intended to treat androgenic alopecia by promoting hair growth. The Theradome Laser Helmet LH80 PRO is a prescription use therapeutic device indicated to promote hair growth in females, with androgenic alopedia, having Ludwig and Savin Hair Loss Scale classification I-II and Fitzpatrick Skin-Types I to IV.
    Device Description
    The Theradome Laser Helmet LH80 PRO is a low level laser therapy (LLT) device used to promote hair growth via photobiostimulation. The lasers are contained inside a lightweight, one-size fits all helmet. The LH80 PRO utilizes laser diodes in the heimet 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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