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755mm: The Elite iQ PRO Laser System is indicated for stable long-term or 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 PRO 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 porkiloderma of Civatte; and treatment of beingn 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 follicultis 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.

The Elite iQ™ PRO 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 PRO 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 PRO 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 PRO software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface. The software of the device was changed to update the fluence levels for the handpieces in order to support the new 30mm handpiece. The new 30 mm handpiece is also part of the DEKA AGAIN PRO device (K233090). The new fluence levels are within range of the previously approved ranges in the Elite iQ device (K193426). The software was also updated to reflect the Elite iQ PRO branding. There are no changes to the principle of use of the device compared to the predicates Elite iQ Laser System (K193426) and DEKA AGAIN PRO (K233090). The labeling of the device has been updated to reflect the name of the device Elite IQ PRO Laser System.

MyEllevate is indicated for use in soft tissue approximation of sub dermis and underlying muscle

The MyEllevate device consists of a Surgical Suture System consisting of synthetic non-absorbable, braided, polyester surgical suture, and a set of instruments designed to efficiently and accurately place the suture for the purpose of performing soft tissue approximation. MyEllevate contains a Skin Marking Tape, a Lancet, a Tunneling Rod, two stainless steel Suturods, and a Light Handle which contains an LED light source. Each Suturod™ has an internal fiber optic "light pipe" which, when connected to the Ligh Handle, illuminates the distal tip of the Suturod™ and permits visual verification of the location and depth of the Suturod™ as it is passed through the subcutaneous space. All components of MyEllevate are provided sterile and are intended for single use only. While the nonabsorbable suture is a Class II device as describes by 21CFR, §878.5000, the remaining instruments are Class I devices exempt from 510(k) requirements. The Lancet, Clearing Device, and Tunneling Rod are manual surgical devices described by 21 CFR §878.4800. The Skin Marking Pen is described in 21 CFR §878.4660, and the fiber optic "light pipe" and Light Handle to illuminate surgical sites, is described in 21 CFR, §876.4530.

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.

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

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, 30mm, 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, 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.

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 Small 10mm Smart Handpiece is now included for the purpose of tissue heating for selected medical conditions and the treatment of mild to moderate facial wrinkles and rhytids. The handpiece is capable of operating at maximum energy setting of 30 (28W) in the Smart Handpiece Mode. There have been no additional changes to the previous existing handpieces (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

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.

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.

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

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

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.

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.

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

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)

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 Body Mass Index (BMI) of 49 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, thighs and submental area. When using the petite mask for non-invasive lipolysis of the submental area, the device can also affect the appearance of lax tissue in the submental area.

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.

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

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