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510(k) Data Aggregation

    K Number
    K242619
    Device Name
    GroWell BT Hair Growth System (GW10042)
    Manufacturer
    Apira Science Inc
    Date Cleared
    2024-12-02

    (90 days)

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

    Apira Science Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MEN - The GroWell BT Hair Growth System ("GroWell") is designed to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V. WOMEN - The GroWell is designed to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin classifications of I-II. The GroWell is approved for Fitzpatrick skin types I-IV.
    Device Description
    The GroWell BT Hair Growth System consists of 24 proprietary red light diode lasers and 39 proprietary red light super-luminescent diodes configured in a flexible panel which is inserted in an adult, baseball-style cap. The GroWell contains 655nm laser and LED diodes, which generates light after being excited by the internal power supply, the light is controlled and output by the control device, and directly and effectively irradiated to the treatment site, so as to achieve therapeutic effect. The GroWell's conbination of diode lasers and non-laser LED's provides for a full coverage of the head: i.e, the scalp area roughly from the top of the head to the top of the ears. The GroWell session will be "paused" and the light array will automatically turn off if the user removes the GroWell during use, and will resume when it is replaced on the 25 minute session, the lights will turn off and the GroWell will emit two audible beeps to signal that the therapy is complete.
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