Search Filters

Search Results

Found 92 results

510(k) Data Aggregation

    K Number
    K190678
    Device Name
    TempSure
    Manufacturer
    Cynosure, Inc
    Date Cleared
    2019-07-24

    (128 days)

    Product Code
    GEI, PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cynosure, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm. 25mm. 30mm. and 60mm handpieces provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite The following surgical modes are applicable to the generator: Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed Cutting: submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage. skin incisions, biopsy, cysts, abscesses. tumors. cosmetic repairs, development of skin flaps. skin tags and blepharoplasty. Blended Cutting and Coagulation: submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids. keratosis, verrucae, basal cell carcinoma. nevi. fistulas. epithelidma. cosmetic repairs. cysts. abscesses. and development of skin flaps. Fulguration: basal cell carcinoma. papilloma. cyst destruction, tumors. verrucae, hemostasis. Bipolar: pinpoint precise coagulation. pinpoint hemostasis in any, field (wet or dry). snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment and turbinate shrinkage
    Device Description
    The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and surgical procedures. The intended action is achieved through application of radiofrequency energy to the patient which results in minimization of heat dissipation and cellular alteration. Output of energy is controlled via the guided user interface (GUI) and the foot and/or hand-switch. An additional 60mm Smart Handpiece is now included for the purpose of tissue heating for selected medical conditions. The 60mm handpiece can also be used with a new massage head for the temporary reduction in the appearance of cellulite. The handpiece has the same maximum output power of 300W in the Smart Handpiece Mode. In addition, a new larger disposable neutral pad is provided for these body treatments. There have been no additional changes to the previous existing handpieces (10, 15, 18, 20, 25, or 30mm) or Surgical modes (COAG, Cut, Blend, Bipolar, Fulgurate) of the system. The TempSure system is still used with the same existing electrosurgical accessories. The TempSure™ System includes: TempSure™ Generator Temperature Sensing Handpieces (10, 15, 18, 20, 25, 30, and 60mm) Massage Heads (25, 30, and 60mm) IEC Power Cord Footswitch Disposable/Reusable Neutral Pads Surgical Fingerswitch/Foot Controlled Handpieces Monopolar Cables Disposable/Reusable Electrodes, Forceps New Additions to the TempSure System include: 60mm Smart Handpiece (ASY-12745) 60mm Massage Head (ASY-12746) Large Neutral Pad (MEL-01197)
    Ask a Question
    K Number
    K182365
    Device Name
    TempSure System
    Manufacturer
    Cynosure, Inc
    Date Cleared
    2018-10-24

    (55 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cynosure, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 25mm, and 30mm handpieces provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite The following surgical modes are applicable to the generator: Coagulation/Hemostasis: General surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage. skin incisions, biopsy, cysts, abscesses. tumors. cosmetic repairs, development of skin flaps. skin tags and blepharoplasty. Blended Cutting and Coagulation: submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids. keratosis, verrucae, basal cell carcinoma. nevi. fistulas. epithelidma. cosmetic repairs. cysts. abscesses. and development of skin flaps. Fulguration: basal cell carcinoma. papilloma. cyst destruction, tumors. verrucae, hemostasis. Bipolar: pinpoint precise coagulation. pinpoint hemostasis in any, field (wet or dry). snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP). myringotomy with effective hemorrhage control. epistaxis treatment and turbinate shrinkage
    Device Description
    The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and surgical procedures. The intended action is achieved through application of radiofrequency energy to the patient which results in minimization of heat dissipation and cellular alteration. Output of energy is controlled via the guided user interface (GUI) and the foot and/or hand-switch. The TempSure generator has been upgraded to include additional surgical modes – Cut, Bipolar, Fulgurate, and Blend, along with the existing Coag. The power of the device for Surgical applications is a maximum of 300W. There have been no changes to the Smart Handpiece treatment with temperature sensitive handpieces. TempSure system is used with the same existing Ellman electrosurgical accessories. The TempSure™ System includes: • TempSure™ Generator • Temperature Sensing Handpieces • IEC Power Cord • Footswitch • Disposable/Reusable Neutral Pad • Surgical Fingerswitch/Foot Controlled Handpieces • Monopolar Cables • Disposable/Reusable Electrodes, Forceps
    Ask a Question
    K Number
    K173199
    Device Name
    PicoSure Workstation
    Manufacturer
    Cynosure, Inc
    Date Cleared
    2018-02-07

    (128 days)

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

    Cynosure, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    755mm: The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure Workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV. 532mm: The PicoSure 532mm Laser Delivery System is indicated for tattoo removal and benign pigmented lesion removal in Skin Types I - III. 1064nm: The PicoSure 1064nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
    Device Description
    The PicoSureTM Workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755nm handpiece, optional 532nm Laser Delivery System and/or 1064nm Laser Delivery System can replace the 755nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755nm laser energy into a 532nm wavelength or a 1064 nm wavelength, and are available in multiple spot sizes.
    Ask a Question
    K Number
    K171992
    Device Name
    SculpSure
    Manufacturer
    Cynosure, Inc
    Date Cleared
    2017-09-26

    (85 days)

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

    Cynosure, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cynosure SculpSure™ 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. In addition, the device is intended for non-invasive lipolysis of the submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area.
    Device Description
    The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
    Ask a Question
    K Number
    K171262
    Device Name
    TempSure
    Manufacturer
    Cynosure, Inc
    Date Cleared
    2017-09-22

    (144 days)

    Product Code
    GEI, PBX
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cynosure, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 10mm, 15mm, and 20mm Portrait handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm, 25mm, and 30mm Portrait handpieces provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Portrait™ massage device is intended to provide a temporary reduction in the appearance of cellulite Coagulation/Hemostasis: Using the surgical handpieces and accessories, general surgical procedures including urologic, thoracic, plastic, reconstructive, and gynecological procedures where electrosurgical coagulation of tissue is performed
    Device Description
    The Cynosure TempSure™ System is a radiofrequency generator with a variety of applications both aesthetic and electrosurgical procedures. The intended action is achieved through application of radiofrequency energy to the patient which results in minimization of heat dissipation and cellular alteration. Output of energy is controlled via the guided user interface (GUI) and the foot and/or hand-switch. The TempSure™ system is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytids, heating for the purpose of elevating tissue temperature for selected medical conditions, and hemostasis/coagulation for general surgery applications. The generator is used with a temperature sensitive handpiece for aesthetic procedures that provides real-time temperature feedback. This temperature information is displayed on the user interface that shows the temperature set point and actual tissue temperature along with procedure time, system error, and warning codes. A thermistor protrudes at the end of the temperature-sensitive handpiece at the point of patient contact, which provides a constant information feedback loop as to the tissue temperature throughout a procedure. The TempSure™ System includes: TempSure™ Surgical RF Generator Portrait™ Temperature Sensing Handpieces IEC Power Cord Footswitch Disposable/Reusable Neutral Pad Surgical Fingerswitch/Foot Controlled Handpieces Monopolar Cables Disposable/Reusable Electrodes
    Ask a Question
    K Number
    K171111
    Device Name
    Sculpsure
    Manufacturer
    Cynosure, Inc
    Date Cleared
    2017-06-13

    (60 days)

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

    Cynosure, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cynosure SculpSure™ 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
    Device Description
    The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
    Ask a Question
    K Number
    K160470
    Device Name
    SculpSure
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2016-07-21

    (153 days)

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

    CYNOSURE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.
    Device Description
    The Cynosure SculpSure is a diode laser system. The main components of SculpSure are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which is used to deliver laser energy to subcutaneous tissue layers.
    Ask a Question
    K Number
    K160480
    Device Name
    PicoSure Workstation
    Manufacturer
    Cynosure, Inc
    Date Cleared
    2016-05-17

    (85 days)

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

    Cynosure, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    755 nm: The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal. The PicoSure workstation with the 2mm and 6mm hand pieces and the Focus Array are indicated for the treatment of acne scars and wrinkles in Skin Types I - IV. 532 nm: The PicoSure 532 nm Laser Delivery System is indicated for tattoo removal in Skin Types I - III. 1064 nm: The PicoSure 1064 nm Laser Delivery System is indicated for tattoo and benign pigmented lesions removal.
    Device Description
    The PicoSure™ workstation is a high-powered, Alexandrite system that delivers laser energy in the 755-nm nominal wavelength. The system offers fast and efficient treatment through a variety of spot sizes, fluences and repetition rates. Laser activation is by footswitch. In addition to the 755 nm handpiece, optional 532 nm Laser Delivery System and/or 1064 nm Laser Delivery System can replace the 755 nm handpiece at the distal end of the articulated arm. These Delivery Systems convert the 755 nm laser energy into a 532 nm wavelength or a 1064 nm wavelength and are available in multiple spot sizes.
    Ask a Question
    K Number
    K150587
    Device Name
    Cortex Laser System
    Manufacturer
    Cynosure, Inc. dba Ellman
    Date Cleared
    2015-07-21

    (134 days)

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

    Cynosure, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, neurosurgery, orthopedics, general and thoracic 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, 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 tags, 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. The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
    Device Description
    The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er: Y AG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
    Ask a Question
    K Number
    K150724
    Device Name
    SculpSure
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2015-07-01

    (103 days)

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

    CYNOSURE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cynosure SculpSure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired affect. Intended for individuals with a Body Mass Index (BMI) of 30 or less.
    Device Description
    The Cynosure SculpSure is a diode laser system. Electrically efficient semiconductors generate optical radiation (1064 nm) which is used to directly irradiate the skin's surface. The Sculpsure is intended for non-invasive lipolysis of the abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. The main components of SculpSure are a console and applicator.
    Ask a Question

    Page 1 of 10