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510(k) Data Aggregation

    K Number
    K240472
    Device Name
    PBM Hair Therapy Cap
    Manufacturer
    Dongguan Tutamen Metalwork Co., Ltd
    Date Cleared
    2024-10-11

    (234 days)

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

    Dongguan Tutamen Metalwork Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PBM Hair Therapy Cap is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I to II, males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss, females and males with frontal patterns of hair-loss both with Fitzpatrick Skin Types I to IV.
    Device Description
    The PBM Hair Therapy Cap is a hair therapy device that uses red light to help stimulate hair growth in both male and females. The device comes with a Cap that has LED diodes inbuilt and an attachable controller battery pack that comes with an automatic timer that limits the user to 15-minute sessions. The device uses only 660nm LED wavelength diodes on 7 strips, each strip has 12 diodes. These diodes strips are sewn into a cap and has a Type C USB connector that the controller battery pack can connect to. The PBM Hair Therapy Cap is comprised of a fabric cap with inbuilt LED diodes that emit red light on the wavelength of 660nm. The diodes are on strips and the cap style hat has 7 strips with 12 diodes on each strip with a total of 84 LED diodes. A battery powered controller that attaches via a C-type USB connector to the fabric hat is also provided. The controller has a built in 3.7V lithium-ion battery, has an on/off button and in programmed to automatically turn of after 15min of use. The controller also has a 2 small indicator LED's for indicating, power on/in use, needs charging and also blinks while in charging mode. The controller charges via inbuilt C-Type USB port and charges at 500 mA.
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