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510(k) Data Aggregation

    K Number
    K200042
    Device Name
    CO2 Laser System
    Manufacturer
    Beijing Superlaser Technology Co., Ltd.
    Date Cleared
    2020-06-09

    (153 days)

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

    Beijing Superlaser Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
    Device Description
    The device emits CO2 laser at the wavelength of 10.6um, which is the spectral line in the far infrared range. The device is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
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    K Number
    K193464
    Device Name
    ND:YAG Laser
    Manufacturer
    Beijing Superlaser Technology Co., Ltd.
    Date Cleared
    2020-04-13

    (119 days)

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

    Beijing Superlaser Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ND: YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and the removal of black or blue tattoos.
    Device Description
    The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm. The device is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, and Birthmark; and the removal of black or blue tattoos. It is for prescription use only.
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    K Number
    K192516
    Device Name
    Diode Laser 808nm
    Manufacturer
    Beijing Superlaser Technology Co., Ltd.
    Date Cleared
    2019-12-10

    (88 days)

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

    Beijing Superlaser Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser 808nm is intended for hair removal, permanent hair reduction on all 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 Diode Laser 808nm 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. The proposed device has six main function modules as following: Water cooling system: Through refrigeration compressor to achieve heat and cold exchange of air, the internal water tank by the water and water pump for cooling water cycle, with cooling water to cool the parts of the tools, the system to achieve this function is called water cooling system. Power system: Through the main circuit control system, according to the control requirements to provide the size of laser energy, the system to achieve this function is called the power system. User Interface system: Through the display screen and touch screen, 1. Provide users with relevant information about display equipment; 2. Users operate or set relevant parameters or functions; 3. Display fault information. The system that realizes this function is called human-machine switching system. Handpiece system: According to the choice of different treatment methods to choose the appropriate treatment tools, the system to achieve this function is called the handpiece system. Main circuit power supply system: The system that realizes the power supply of equipment and the control switch or stops the power supply is called the main circuit power supply system. Main circuit control system: It is used to control the parts of the equipment to work in a reasonable sequence and provide fault or warning sound. The system that realizes this function is called the main circuit control system.
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    K Number
    K192519
    Device Name
    Multi-modality workstation
    Manufacturer
    Beijing Superlaser Technology Co., Ltd.
    Date Cleared
    2019-11-27

    (75 days)

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

    Beijing Superlaser Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi-modality workstation (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. 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 regimen.
    Device Description
    The Multi-modality workstation is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 520mm. 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 Systems 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. Based on this, the Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.
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