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510(k) Data Aggregation

    K Number
    K223292
    Device Name
    TempSure System
    Manufacturer
    Cynosure LLC
    Date Cleared
    2022-11-23

    (28 days)

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

    Cynosure LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Small 10mm, 10mm, 15mm, and 20mm handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The Small 10mm, 18mm, 25mm, and 60mm handpieces and the FlexSure™ Applicators 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: snoring, 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, epithelioma, 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. There have been no changes to the TempSure Device or handpieces (Small 10, 10, 15, 18, 20, 25, 30 or 60mm), FlexSure Applicators, 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 (Small 10, 10, 15, 18, 20, 25, 30, and 60mm) • Massage Heads (25, 30, and 60mm) • FlexSure™ Applicators (Large and Medium) • IEC Power Cord • Footswitch • Disposable/Reusable Neutral Pads • Surgical Fingerswitch/Foot Controlled Handpieces • Monopolar Cables • Disposable/Reusable Electrodes, Forceps
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    K Number
    K210226
    Device Name
    PicoSure Workstation
    Manufacturer
    Cynosure LLC
    Date Cleared
    2021-03-30

    (61 days)

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

    Cynosure LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    755mm: The PicoSure Workstation is indicated for tattoo and benign pigmented lesions removal including but not limited to: Nevus of Ota, Hori macules (nevus of Hori), and Melasma. 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. 532nm: The PicoSure 532-nm delivery system is indicated for tattoo removal and benign pigmented lesions removal in Skin Types I-III. 1064nm: The PicoSure 1064-nm 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 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.
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    K Number
    K200241
    Device Name
    TempSure System
    Manufacturer
    Cynosure LLC
    Date Cleared
    2020-03-25

    (54 days)

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

    Cynosure LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 10mm, 15mm, and 20mm Smart Handpieces are indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytids. The 18mm, 25mm, 30mm, 60mm Smart Handpieces and FlexSure™ applicators 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 FlexSure TM Applicators are now included for the purpose of tissue heating for selected medical conditions. The applicator comes in 2 sizes (large and medium) and has the same maximum output power of 300W in the Smart Handpiece Mode. The FlexSure applicator utilizes the larger disposable neutral pad. There have been no changes to the Smart Handpiece (10, 15, 18, 20, 25, 30 or 60mm) 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) Temperature Sensing single use applicator (FlexSure) 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: • FlexSure™ Large Applicator • FlexSure™ Medium Applicator
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    K Number
    K193426
    Device Name
    Elite iQ
    Manufacturer
    Cynosure LLC
    Date Cleared
    2020-03-09

    (90 days)

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

    Cynosure LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    755mm: The Elite iQ Laser System is indicated for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completion of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064nm: The Elite iQ Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of pseudo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as 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. The Skintel Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.
    Device Description
    The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin. The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.
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