Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K222916
    Device Name
    US 450 Diode Laser Equipment
    Date Cleared
    2022-12-09

    (74 days)

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

    Beijing Globalipl Development Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The US 450 Diode Laser Equipment is intended for hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    US450 Diode Laser Equipment is a device which adopts the high-energy and continuous diode laser to realize the conversion of electricity, light and heat energy, and thus achieves disease treatment. Therefore, this is a laser therapeutic product that integrates laser technology, electronic technology, computer science and medical science. Under the control of microprocessor, laser power supply can provide the adjustable constant current for the laser module, the high power laser diode in the laser module can transform the electric energy into the light, generate the continuous laser beam with a wavelength of 808mm. Semiconductor laser used for hair removal is mainly based on the principle of selective photothermal action, that is, a specific wavelength of laser can only be selectively absorbed by the target color base. US450 Diode Laser Equipment consists of power supply system, microprocessor control system, operation display system, cooling system, treatment handle and safety alarm system.
    Ask a Question

    Ask a specific question about this device

    K Number
    K220385
    Device Name
    Intense Pulsed Light Equipment
    Date Cleared
    2022-08-12

    (183 days)

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

    Beijing Globalipl Development Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The US 500 Intense Pulsed Light Equipment is indicated for use in surgical and aesthetic applications in permanent hair removal. Permanent hair removal is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
    Device Description
    The USS00 Intense Pulsed Light Equipment is a device that emits intense pulsed light in order to achieve hair reduction. The light source is a Xenon lamp that emits light which is filtered to include suitable wavelengths for hair reduction. The device is electrically powered, and main components include the console which includes electrical components and a touchscreen user interface, the IPL handpiece and cable, and a footswitch. The light pulses are emitted from the handpiece which is water cooled. The device is for prescription use only.
    Ask a Question

    Ask a specific question about this device

    K Number
    K212611
    Device Name
    CO2 Laser Equipment
    Date Cleared
    2022-02-01

    (168 days)

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

    Beijing Globalipl Development Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CO2 Laser Equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
    Device Description
    The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 um wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 Laser Equipment includes two models US800/US800N, the two models have same mechanism of action, structure, material, motherboard, software, principle and specification. The difference is appearance and size.
    Ask a Question

    Ask a specific question about this device

    K Number
    K193328
    Device Name
    IPL + Diode Laser Machine
    Date Cleared
    2020-03-25

    (114 days)

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

    Beijing Globalipl Development Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The proposed device, IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions, and (inclusive of the handpiece used to deliver diode laser energy)is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. IPL are intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 480mm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin. IPL are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Diode Laser machine is based on the principles of selective photothermolysis (SPTL): a combination of the appropriate laser wavelength, pulse duration, and fluence can obtain optimal effect on a targeted tissue with minimal effect on surrounding tissue. Wavelengths of 808 nanometers (nm) are widely used in hair removal treatment, it is selectively absorbed by melanin in the hair shaft, damaging the follicular epithelium, and further causes hair loss, while the competing chromophores (oxyhemoglobin and water) absorb less energy at these wavelengths. The user could power on the device and use the key switch to start the system, and then set the output parameter, when the setting is done, the user could use the handpiece to aim the area to be treated by 808 nm laser delivering , the laser emitting could be triggered by foot switch controlled by user. Function module description: Control Panel, Main Control Module, Constant current board module, Temperature and humidity control system, Handpiece module.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1