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510(k) Data Aggregation

    K Number
    K241670
    Device Name
    Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
    Manufacturer
    Beijing ADSS Development Co., Ltd.
    Date Cleared
    2024-12-20

    (192 days)

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

    Beijing ADSS Development Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology plastic surgery and general surgery.
    Device Description
    Fractional CO2 Laser Therapy System consists of a main unit, a light guide arm (including a treatment head), a foot switch, and protective goggles. The fractional CO2 laser penetrates directly into the dermis utilizing the thermal effect of laser, instantly vaporizes the tissue in the lesion area. Parameters such as the laser energy density required for the treatment are set by the user appropriately. The Fractional CO2 Laser Machine has two operational modes, fractional mode and normal mode.
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    K Number
    K233307
    Device Name
    Intensity Pulsed Light Therapy System
    Manufacturer
    Beijing ADSS Development Co., Ltd.
    Date Cleared
    2024-03-15

    (168 days)

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

    Beijing ADSS Development Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intensity Pulsed Light Therapy System is intended for medical use in the treatment of the following conditions: -Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); -Cutaneous lesions including scars; - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations. -Permanent hair reduction-long-term stable reduction in number of hairs re-growing after a treatment regimen.
    Device Description
    Not Found
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    K Number
    K231896
    Device Name
    Diode Laser Therapy System
    Manufacturer
    Beijing ADSS Development Co., Ltd.
    Date Cleared
    2024-02-20

    (237 days)

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

    Beijing ADSS Development Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser Therapy System (Model: FG2000-B/FG2000-B Pro) is indicated for temporary hair reduction. The Diode Laser Therapy System(Model: FG2000-D+Pro/FG2000-D) is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
    Device Description
    The Diode Laser Therapy System consists of main unit, handpiece, and its accessories. Diode Laser Therapy System is intended for hair removal, mainly based on the principle of selective photothermal interaction, which means that lasers of specific wavelengths can only be selectively absorbed by the target color base. The Diode Laser Therapy System(Model: FG2000-B/FG2000-B Pro) are desktop devices, which combines 3 wavelengths (755+808+1064 nm) into a single handpiece to achieve purpose for temporary hair reduction. The Diode Laser Therapy System (Model: FG2000-D+Fro/ FG2000-E) are vertical device, which is a single wavelength (808 nm only) device.
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    K Number
    K231318
    Device Name
    Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
    Manufacturer
    Beijing ADSS Development Co., Ltd.
    Date Cleared
    2023-07-07

    (60 days)

    Product Code
    NGX
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing ADSS Development Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated to be used for: - · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - Strengthening, Toning and Firming of buttocks and thighs.
    Device Description
    The Electromagnetic stimulator device consists of a host, hand tools and power cord. The host contains a power supply unit, a control unit, and a cooling unit. The control unit includes a control element and a liquid crystal display. The hand tools include electromagnetic induction coils and cooling fans, it is a non-invasive therapeutic device. The subject device has two models, Tesla Duet and EM contouring. The two models are exactly the same except for the color of the host shell, one is black and other is white. The device produces electromagnetic field that interacts with the tissues of the human body. By muscle stimulation, the Electromagnetic stimulator device helps to strengthen, tone and firm the abdomen, buttocks and thighs. The device two outputs enable simultaneous treatment by two applicators. The Electromagnetic stimulator device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen and buttons on the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.
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    K Number
    K220268
    Device Name
    Picosecond Laser System (Model PS10-A and PS10-B)
    Manufacturer
    Beijing ADSS Development Co., Ltd.
    Date Cleared
    2022-08-23

    (204 days)

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

    Beijing ADSS Development Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Picosecond Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. 532nm wavelength: - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
    Device Description
    The Picosecond Laser System consists of a host, a treatment handpiece, a light guide system, a foot switch, power cords and accessories. The host contains a laser, a cooling device, a laser power supply, a control device (including a control device and a LCD) and a protective device. Accessories include a foot switch, a laser protective qlasses, power cords, and a water filling device. The Picosecond Laser System is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce two laser wavelengths (i.e., 1064 nm and 532 nm).
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    K Number
    K192295
    Device Name
    PDT-FACE
    Manufacturer
    Beijing ADSS Development Co., Ltd.
    Date Cleared
    2020-05-01

    (252 days)

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

    Beijing ADSS Development Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. The device is indicated for adults only.
    Device Description
    The LED THERAPY DEVICE is a facemask-shaped device, which directly applies light onto the face skin surface and makes use of specific light spectral characteristics. The proposed device has total of 150 LEDs and operates in two modes. One mode emits blue light with wavelengths centered at 415nm ±5nm, and the other mode emits red light with wavelengths centered at 630nm ±5nm. The red light is intended for the treatment of wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne. The blue light mode has ten level energy output settings, 5mw/cm2-50mw/cm2. The red light mode has ten level energy output settings, 8mw/cm2-80mw/cm2. The user can change the treatment mode according to their own needs. The LED THERAPY DEVICE is powered via a plug-in power adapter.
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    K Number
    K161926
    Device Name
    ND YAG Q-switch Laser Therapy Machine
    Manufacturer
    Beijing ADSS Development Co., Ltd
    Date Cleared
    2017-02-22

    (224 days)

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

    Beijing ADSS Development Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ND YAG Q-switch Laser Therapy Machine 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.
    Device Description
    The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm. There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations.
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    K Number
    K161692
    Device Name
    Diode Laser Therapy Machine
    Manufacturer
    BEIJING ADSS DEVELOPMENT CO., LTD
    Date Cleared
    2016-11-16

    (149 days)

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

    BEIJING ADSS DEVELOPMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser Therapy Machine 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, Diode Laser Therapy System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); There are 4 models included, FG 2000, FG 2000-B, FG 2000-C and FG 2000-D, the four models have same intended use, mechanism of action, principle and specification, only difference is the configuration. The main components of proposed device shown as following: Handpiece, Touchscreen, Emergency Switch, Key Switch, Connector, Indicator Lamp, Foot Switch. The proposed system provides 36 working modes, which are six modes for men and six modes for women, the men or women mode includes face, armpit, arm, body, bikini, leg mode respectively for different treatment part, and each particular treat mode includes three submode as mode 1, mode 2 and mode 3. The difference for each mode is only the default parameters for each mode can be adjustable in the parameter range. The treatment can be applied on different Fitzpatrick skin type, including I (White), II (White with pigment), III (Yellow), IV (Yellow with pigment), V (Brown) and VI (Black);
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    K Number
    K161925
    Device Name
    CO2 Laser Therapy Machine
    Manufacturer
    Beijing ADSS Development Co., Ltd
    Date Cleared
    2016-10-05

    (84 days)

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

    Beijing ADSS Development Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 Laser Therapy Machine is used for human tissue vaporization in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
    Device Description
    The CO2 Laser Therapy Machine 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 proposed device is mainly used for human tissue vaporization, carbonization, coagulation and exposure to achieve the purpose of treatment. The CO2 Laser Therapy Machine includes three models in this submission, FG 900, FG 900-B and FG 900-C, all three models have same principle, software, operation etc., only differences are appearance. The proposed device includes the following components: Surgery tip, Surgery tip Arm, Touchscreen, Emergency Switch, Key Switch, Goggles for Patient, Goggles for Doctor, Foot Switch.
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