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510(k) Data Aggregation

    K Number
    K222265
    Device Name
    Diosculpt
    Manufacturer
    Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.
    Date Cleared
    2022-09-23

    (57 days)

    Product Code
    PKT
    Regulation Number
    878.5400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DioSculpt laser system is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    The DioSculpt laser lipolysis system is a diode laser system, Electrically efficient semiconductor generate optical radiation (1060nm) which is used to deliver laser energy to subcutaneous tissue layers. DioSculpt's cooling and electical systems assist in maintaining safe and comfortable skin surface temperatures.
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    K Number
    K161356
    Device Name
    Matrix LS-40 CO2 Laser System
    Manufacturer
    SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD.
    Date Cleared
    2016-09-09

    (116 days)

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

    SHANGHAI WONDERFUL OPTO-ELECTRICS TECH. CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing. The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery. Dermatology, Plastic Surgery and General Surgery procedures: - Laser skin resurfacing. - Treatment of furrows and wrinkles. - Removal of skin taqs, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation. - Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. - Blepharoplasty. - Site preparation for hair transplants. - The fractional scanner is for skin resurfacing.
    Device Description
    The MATRIX LS-40 CO2 Surgical laser System incorporating a permanently articulated arm that delivers CO2 laser power in a wavelength of 10,600nm in its normal operations. The device is activated by means of a footswitch. The Laser System is designed for use in an office or a clinic, which shall be a clean, dry and well-ventilated room with a door.
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