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510(k) Data Aggregation

    K Number
    K193008
    Device Name
    Tricoglam Home Use
    Manufacturer
    Advihair S.R.L.
    Date Cleared
    2020-12-03

    (402 days)

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

    Advihair S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tricoglam Home Use is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood Hamilton Classifications IIa - V and for both, Fitzpatrick Classification of Skin Phototypes of I - IV.
    Device Description
    Tricoglam Home Use is a white and grey plastic helmet and inside is housed an electronic board with all the electrical components and a series of LED diodes on a wavelength, protected by a transparent plastic. The energy is distributed homogeneously. This Helmet is composed by 105 red LEDs arranged uniformly inside the helmet with a wavelength of 650 nm +/- 10 nm. The program consists of the lighting of all the red diodes for a duration of 20 min in continuous (every day). To start the treatment the user should press the button on the back and activate the program. All LEDs light up and, after the pre-set 20 minutes, all LEDs turn off.
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