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510(k) Data Aggregation

    K Number
    K182501
    Device Name
    Hair Laser Headband
    Manufacturer
    Pulsaderm LLC
    Date Cleared
    2018-10-26

    (44 days)

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

    Pulsaderm LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laser Headband is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, or frontal, both with Fitzpatrick Skin Types I to IV.
    Device Description
    Similar to the Hair Laser Helmet, the Hair Laser Headband 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 distributed laser light to the scalp at 655 +/- 5 nanometers with an individual laser output of 5mW per laser diode. The lasers are configured inside a headband, designed for hands-free operation during treatment. The laser headband is for portable use with rechargeable battery.
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    K Number
    K170111
    Device Name
    Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37
    Manufacturer
    Pulsaderm LLC
    Date Cleared
    2017-05-08

    (116 days)

    Product Code
    OLP
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Pulsaderm LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are intended for over the counter use for the treatment of mild to moderate acne.
    Device Description
    Pulsaderm Acne Mask 28 and Pulsaderm Acne Mask 37 are class II Medical Devices that use Light Emitting Diodes to apply low power monochromatic and non-coherent light in the red and blue range, to treat mild to moderate acne. The devices are powered by Ni-MH rechargeable batteries.
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    K Number
    K163329
    Device Name
    Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
    Manufacturer
    PULSADERM LLC
    Date Cleared
    2017-04-14

    (137 days)

    Product Code
    OHS
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PULSADERM LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pulsaderm Wrinkle Mask 28 and 72 are intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I,II and/or III.
    Device Description
    The Pulsaderm Wrinkle Mask 28 and Wrinkle Mask 72 are over the counter devices and consist of a collection of red and infrared diodes for the treatment of facial wrinkles. Pulsadern Wrinkle Masks 28 and 72 are powered rechargeable Ni-MH batteries. To receive treatment, the user simply places the mask over the face for a specific period to receive treatment.
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