Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K160728
    Device Name
    NutraStim Hair Laser Helmet
    Manufacturer
    NUTRA LUXE MD LLC
    Date Cleared
    2016-09-16

    (184 days)

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

    NUTRA LUXE MD LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NutraStim Hair Laser Helmet is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of IIa to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale I-4, II-1, II-2, or frontal, both with Fitzpatrick Skin Types I to IV.
    Device Description
    NutraStim Hair Laser Helmet is a low-level laser device and is intended/indicated for over- the -counter use. The device emits laser light with the intention to promote hair growth. The device provides timed treatments of distributed laser light to 100% of the scalp at 650 +/- 5 nanometers. The lasers are configured inside a helmet, designed for hands-free operation during treatment. The helmet is for portable use with rechargeable battery and adapter.
    Ask a Question

    Page 1 of 1