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510(k) Data Aggregation

    K Number
    K200464
    Device Name
    LG Pra. L Derma LD Scalp Care
    Manufacturer
    LG Electronics, Inc.
    Date Cleared
    2020-07-23

    (148 days)

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

    LG Electronics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LG Pra.L Derma LD Scalp Care is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of IIa-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The LG Pra.L Derma LD Scalp Care utilizes a combination of laser diodes and light-emitting diodes (LEDs). 5-milliwatt laser diodes emit light from a range of wavelengths of about 650 nm to 667 nm, which is combined with light from 5 milliwatt LEDs emitting wavelengths from about 645nm to 665 nm. The combined light is absorbed by the scalp. The LG Pra.L Derma LD Scalp Care is a dome shaped helmet with laser diodes and LEDs on the inside surface. By connecting a controller, the user can power the device on and off, start and pause treatment, and change the care mode. In addition, there is a charging cradle to place the controller in to charge the battery, and the status of the battery is displayed on the controller's indicator. The device can also be connected wirelessly via Bluetooth to a Smartphone App in order to manage treatment. After a treatment is completed, the LG Pra.L Derma LD Scalp Care device can automatically power off the laser, LEDs and controllers.
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    K Number
    K183671
    Device Name
    LG PRA.L DERMA LED MASK
    Manufacturer
    LG Electronics, Inc.
    Date Cleared
    2019-01-22

    (26 days)

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

    LG Electronics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LG PRA.L DERMA LED MASK is an over the counter device that is intended for the use in the treatment of full face wrinkles.
    Device Description
    The LG PRA.L DERMA LED MASK is a device which allows emission of LED light in the RED (637 nm) and IR (854 nm) spectrum on to the face. The LG PRA.L DERMA LED MASK includes the mask that contains LEDs on the inner surface, the controller which turns on and off the device, and the power supply unit that delivers electrical power to the controller for operation or for charging the battery contained in the controller. Users place the lightweight mask over the face and use the controller to operate the LG PRA.L DERMA LED MASK. The device will automatically turn off after each treatment. Emitted light from LEDs are not intended for ocular or ophthalmic treatment. To prevent irradiation of LED lights to eyes during the treatment, LG PRA.L DERMA LED MASK has protective eye-shield which blocks light energy from LEDs.
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