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    K Number
    K110984
    Device Name
    SLIM E30 II CO2 LASER
    Manufacturer
    LASERING S.R.L.
    Date Cleared
    2011-07-22

    (106 days)

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

    LASERING S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SLIM Evolution II CO2 Laser and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. Dermatology, Plastic Surgery and General Surgery procedures. Laser skin resurfacing Treatment of furrows and wrinkles Removal of skin tags, actinic keratosis, acne scars, keloids, tattos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation. Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty Site preparation for hair transplants MiXto fractional scanner only for treatment of wrinkles and skin resurfacing Dental procedure including. Periodontal procedures such as - gingivectomy, removal of hyperplasias, gingivoplasty (incision and excision) Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign/malignant lesion ablation, operculectomy and homeostasis Podiatry procedures. Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares. Otorhinolaryngology (ENT) procedures. Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps. Gynecology Treatment of condyloma acuminata, cervical intraevithelial neoplasia. leukoplakia and vulvar/vaginal intraepithelial neoplasia. cervical dysplasia. Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimbroplasty, Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids
    Device Description
    SLIM Evolution II CO2 Laser and Delivery Device Accessories.
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    K Number
    K063001
    Device Name
    SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES
    Manufacturer
    LASERING S.R.L.
    Date Cleared
    2007-03-07

    (156 days)

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

    LASERING S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SLIM Evolution Family of CO2 Lasers and delivery device accessories are intended for use in surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. Dermatology, Plastic Surgery and General Surgery procedures including but not limited to - Laser skin resurfacing Treatment of furrows and wrinkles Removal of skin tags, actinic keratosis, acne scars, keloids, tattos, telangiectasia, squamous and basel cell carcinoma, warts and uneven pigmentation. Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty Site preparation for hair transplants Dental procedure including but not limited to - Periodontal procedures such as -- gingivectomy, removal of hyperplasias,gingivoplasty (incision and excision) Oral Surgery procedures such as - aphous ulcer excision, frenectomy, benign/malignant lesion ablation, operculectomy and homeostasis Podiatry procedures including but not limited to - Ablation, vaporization and excision of soft tissue lesions such as ingrown nail, fungal nail, porokeratoma, matrixectomy and verrucae vulgares. Otorhinolaryngology (ENT) procedures including but not limited to - Treatment of leukoplakia of larynx, nasal obstruction, rhinophyma, verrucrea vulgares, choanal atresia, rhinophyma, LAUP and papillomatosis polyps. Gynecology Treatment of condyloma acuminata, cervical intraepithelial neoplasia, leukoplakia and vulvar/vaginal intraepithelial neoplasia, cervical dysplasia. Laparoscopic treatment endometrial lesions, ablation of endometriosis, fimbroplasty, Tubal microsurgery, salpingostomy, histerectomy, uterine myomas and fibroids
    Device Description
    The SLIM Evolution Family of CO2 Lasers emit a beam of coherent light at the wavelength 10.6 microns in either continuous wave or pulse mode. Each laser consists of a self-contained console, an articulated arm delivery system, a footswitch, safety goggles and warning label set. The main console contains a DC-excited sealedoff CO2 gas tube, micro-controller, articulated arm mount, internal closed circuit cooling system and power supply. The console has an on-off key switch and emergency stop push button. The articulated arm connects the console to focusing handpieces, waveguides, scanner and micromanipulator delivery accessories. Refer to the enclosed brochure and instruction manual for complete published information.
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    K Number
    K063396
    Device Name
    VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES
    Manufacturer
    LASERING S.R.L.
    Date Cleared
    2007-01-17

    (69 days)

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

    LASERING S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue. Velure S5 532nm (Green) Diode Laser Applications: Vascular Lesions, Pigmented Lesions Velure S8/15, Velure S8/30 and Velure S800 808nm Diode Laser Applications: Vascular Lesions, Unwanted Hair Removal Velure S9/15, Velure S9/30 980mm Diode Laser Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urgology Velure S9/7D and Velure S9/15D 980nm Diode Laser Applications: Oral and Periodontal Surgery, Bleaching (tooth whitening)
    Device Description
    The Velure Family of Diode Lasers emit a beam of coherent light in either continuous wave or pulse mode at the following wavelengths: 523nm - Velure S5, 808nm - Velure S8/15, Velure S8/30 and Velure S800, 980nm - Velure S9/7D, Velure S9/15, Velure S9/15D and Velure S9/30. Each laser consists of a self-contained console, an SMA fiber delivery system with handpiece, a footswitch, safety goggles and warning label set. The main console contains a Diode laser, a 635nm pilot laser, micro-controller, air cooling system and power supply. The console has an on-off key switch and emergency stop push button. The SMA fiber delivery system connects the console to a variety of fiber optic handpieces and scanner (Velure S5 only).
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