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510(k) Data Aggregation

    K Number
    K123483
    Device Name
    DIODE LASER
    Manufacturer
    BEIJING SYNTECH LASER CO., LTD.
    Date Cleared
    2013-04-21

    (159 days)

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

    BEIJING SYNTECH LASER CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser is intended for use in dermatologic and general surgical procedures. The Standard Mode is intended for hair removal, permanent hair reduction. The FHR Mode is intended for hair removal, permanent hair reduction. The diode laser system is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
    Device Description
    The diode laser is a surgical device intended for use in dermatologic and general surgical procedure. It utilizes a semiconductor diode with invisible infrared radiation as a laser source (808 nm). The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a footswitch. The diode laser emits 808nm wavelength laser which is absorbed by melanin and at the same time greatly reduce the absorption by water and haematoglobin. The laser beam penetrates through epidermis into dermis and absorbed by melanin in hair and hair follicle, producing laser photothermal effect, conducting the energy from hair section to hair toot, rising temperature of melanin and decomposing it, thus reaching effect of hair removal. During treatment, the Sapphire in handpiece assures reliable and constant cooling result for skin surface with the maximum comfort and safety. When the laser system starts to release energy, skin cooling system works automatically. The cooling system reduces the temperature of treatment area and increase treatment comfort. The proposed device includes power supply system, central control system, cooling system, laser deliver system and safety feature. The cover material of the proposed device is ABS (Acrylonitrile Butadiene Styrene) plastic. The patient contact components in laser handpiece include supporting plate which is made of stainless steel and crystal which is made of sapphire.
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    K Number
    K113018
    Device Name
    APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORM
    Manufacturer
    BEIJING SYNTECH LASER CO., LTD.
    Date Cleared
    2012-12-14

    (430 days)

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

    BEIJING SYNTECH LASER CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light Based Platform, the three models have the same intended use. They can be used in dermatology, cosmetic medicine, and other surgical applications according to the different handpieces. The specific indications should reference to the indications of each handpiece. 1) Er:YAG laser handpiece: - Incision, excision, ablation, vaporization of soft tissue . - The non-ablative treatment of facial wrinkles - 2) Long Pulse Nd:YAG Laser Handpiece: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment . of PFB. - 3) Q-Switch Nd:YAG Laser Handpiece: Tattoo Removal: Dark Ink: (Black & Blue) Nevus of Ota Skin resurfacing procedures for the treatment of acne scars and wrinkles - 4) IPL Handpiece: The Intense Pulsed Light wavelengths are 515-1200 nm HR (Hair Removal): 650-1200 nm The removal of unwanted hair from skin types I-V, and to effect stable long-term, or permanent, hair reduction in skin types I-V through selective targeting of melanin in hair follicles SR (Skin Remove): 570-1200nm The treatment of benign pigmente (epidermal and cutaneous) lesions, such as warts. VR (Vascular and Pigmented Lesion Removal): 515-1200nm The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, polkiloderma of civate; leg veins, and venous malformations.
    Device Description
    APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light. Based Platform, the three models have the same modules and handpieces. The equipment configuration is the only difference among the three models. APOLLO V+ Medical Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The APOLLO V+ Medical Platform has three laser handpieces of Er: YAG laser, Long Pulse Nd: YAG Laser, and Q-Switch Nd: YAG Laser, and one IPL handpiece. APOLLO IV+ Medical Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The APOLLO IV+ Medical Platform has three laser handpieces of Er: YAG laser, Long Pulse Nd: YAG Laser, and Q-Switch Nd:YAG Laser, and one IPL handpiece. There is one difference between APOLLO IV+ Medical Platform and APOLLO V+ Medical Platform, it is "desktop" style for APOLLO IV+ Medical Platform, and a standard case, with wheels to allow easy movement on the floor, for APOLLO V+ Medical Platform. Nice Station Light Based Platform is a modular multifunction device. The equipment can be used in dermatology, cosmetic medicine and other surgical according to the different handpieces. The Nice Station Light Based Platform has three laser handpieces of Er:YAG laser, Long Pulse Nd:YAG Laser, and Q-Switch Nd: YAG Laser, and one IPL handpiece. The Nice Station Light Based Platform has a standard case, with wheels to allow easy movement on the floor. The difference between Nice Station Light Based Platform and APOLLO V+ Medical Platform is the appearance. The user can activate laser emission, IPL emission by means of a footswitch. APOLLO V+ Medical Platform / APOLLO IV+ Medical Platform / Nice Station Light Based Platform includes: a) Power supply The system provides energy for the operation of equipment. b) Control system The system controls the cooling system, Laser emission and delivery system and safety features according the setting parameter which is set by user via the user interface. c) User interface User sets treatment parameter via the user interface. d) Cooling system, The cooling system consists of whole device cooling and IPL handpiece skin cooling. e) Laser emission and delivery system f) Safety features The safety features are used to ensure the equipments is operated properly, such as key switch, -- emergency stop switch and interlock control unit. g) Many handpiece types - Er: YAG handpiece, 2940 nm wavelength t - . Long Pulse Nd: YAG laser handpiece, 1064 nm wavelength - . Q-Switch Nd: YAG laser handpiece, 1064 nm wavelength - IPL handpiece. 650-1200nm wavelengths in RH filter, 570-1200nm wavelengths in SR filter, 515-1200 nm wavelengths in VR filter. All of the housing of handpieces are made of ABS (Acrylonitrile Butadiene Stryene), These handpieces can be removed by the user and interchanged. The principle of generation and treatment of energy sources There are three kinds of energy sources, laser energy, IPL energy The principle of generation and treatment of laser energy . In laser handpiece, there is one optical cavity containing the laser crystal (such as Er. Y AG crystal, Nd:YAG crystal). The laser beam is activated by means of the use of Xenon lamps. This beam is directed to the treatment zone by means of a laser viewfinder. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect. The principle of generation and treatment of IPL energy In IPL module, the IPL (Intense Pulsed Light) which is activated by means of the use of Xenon lamp is directed to the treatment zone via the sapphire in selectable wavelengths. The IPL works on the principle of selective photothermolysis. That is, causing thermal damage to target tissue by using light of appropriate wavelength. The IPL is different from lasers in that it has many wavelengths in each pulse of light instead of just one wavelength. There are three filtered light guide for the selection of the wavelengths range.
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    K Number
    K110434
    Device Name
    TRIXEL CO2 LASER
    Manufacturer
    BEIJING SYNTECH LASER CO., LTD.
    Date Cleared
    2011-04-19

    (63 days)

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

    BEIJING SYNTECH LASER CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The equipment is used for human tissue vaporization. coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology, The equipment is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology,
    Device Description
    Trixel CO2 Laser is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement. The equipment is mainly used for human tissue vaporization, coagulation and exposure to achieve the purpose of treatment.
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