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The UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.

The UltraShape Power System is comprised of multiple components, including the control unit and an ultrasonic transducer. The UltraShape Power System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.

The SlimShape System is indicated for non-invasive lipolysis (breakdown of fat) of the abdomen. The device is indicated for reduction in circumference of the abdomen.

The SlimShape System is comprised of a console and an applicator that delivers radiofrequency energy to the fat tissue and also applies mechanical vacuum to the treatment area. The SlimShape System is designed to enable hands-free abdominal treatment that is based on a predefined user protocol. The system also incorporates a skin temperature control mechanism as a safety feature during treatment. Users interface with and control the SlimShape System via the touch-screen panel.

The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and fat reduction in the flanks and thighs.

The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducers are electro-mechanical devices that convert an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle. The UltraShape System has two treatment modes available, the Single Focus Deep Mode and the Super Mode.

The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) for lipolysis (breakdown of fat) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference and for use on the flanks.

The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducers are electro-mechanical devices that convert an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle. The UltraShape System has two treatment modes available, the Single Focus Deep Mode and the Super Mode.

The UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.

The UltraShape Power System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape Power System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducers are electro-mechanical devices that convert an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape Power System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle. The primary purpose of this submission is to add an increased acoustic intensity level to the device. Additional minor changes since the prior clearances were also included as part of this submission.

The CO2RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including; aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee), The CO-RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin. The Standard Handpiece of the COJRE System is indicated for the following: Dermatology & Plastic Surgery The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: - laser skin resurfacing . - laser dermabrasion - . laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of: wrinkles, rhytids, and furrows (including fines and texture irregularities) . Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: - keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, . seborrheic wart, and verruca seborrheica; - . vermillionectomy of the lip; - cutaneous horns; - solar/actinic elastosis; ● - chelitis, including actinic chelitis; ● - lentigines, including lentigo maligna or Hutchinson's malignant freckle - uneven pigmentation/ dyschromia; - acne scars; - surgical scars: ● - keloids including acne keloidalis nuchae; - . hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum); - . tattoos; - telangiectasia; - removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ● - superficial pigmented lesions: . - adenosebaceous hypertrophy or sebaceous hyperplasia; . - . rhinophyma reduction; - cutaneous papilloma (skin tags): - milia: - . debridement of eczematous or infected skin; - basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; - nevi, including spider, epidermal and protruding; - neurofibromas: - laser de-epithelialization: . - tricoepitheliomas; - xanthelasma palpebrarum; ● - . svringoma Laser ablation, vaporization and for excision for complete or partial nail matrixectomy. Vaporization/coagulation of: - benign/malignant vascular/avascular skin lesions; . - Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts. Podiatry Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: . verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts; - . fungal nail treatment; - porokeratoma ablation: - ● ingrown nail treatment; - neuromas/fibromas, including Morton's neuroma: ● - debridement of ulcers; - other soft tissue lesions. . Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy. Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: ● leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue; - nasal obstruction: ● - adult and juvenile papillomatosis polyps; - polypectomy of nose and nasal passages; ● - lymphangioma removal; ● . removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tonque and vocal cords; ● superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease; - rhinophvma: - verrucae vulgares (warts); Gynecology (GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: . conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; - . leukoplakia (vulvar dystrophies); - herpes vaporization; ● - urethral caruncle vaporization; ● - . cervical dysplasia: - benign and malignant tumors; ● Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: - treatment of ulcerous lesions, including aphthous ulcers; ● - excision and ablation of benign and malignant lesions; ● - leukoplakia; Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: - benign and malignant lesions of external genitalia; ● - condyloma: - erythroplasia ● The Fractional Handpiece of the CO2RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin. The Surgical Handpiece of the CO2RE System is indicated for the following: Dermatology & Plastic Surgery Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: - . vermillionectomy of the lip; - cutaneous horns: - removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ● - . rhinophyma reduction; - basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease . (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions: - . neurofibromas: Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: - benign/malignant vascular/avascular skin lesions; . - . Moh's Surgery; - Lipectomy; . - Verrucae and seborrhoecae vulgares, including paronychial, periungal, and ● subunqual warts. Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty. Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation. Podiatry Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of: - . verrucae vulgares/plantar (warts), including paronychial, periungal, and subunqual warts: Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy. Otolaryngology (ENT) Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of: - choanal atresia, - nasal obstruction: - adult and juvenile papillomatosis polyps; - polypectomy of nose and nasal passages; - lymphangioma removal; ● - removal of vocal cord/fold nodules, polyps and cysts; - . removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords; . laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue; Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-● assisted esophaqodivertuculostomy (ELAED)]; - stenosis, including subglottic stenosis; ● tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; - pulmonary bronchial and tracheal lesion removal; benign and malignant nodules, tumors and fibromas (larynx, pharynx, ● trachea, tracheobronchial/endobronchial); - benign and malignant lesions and fibromas (nose and nasal passages); - benign and malignant tumors and fibromas (oral); - stapedotomy/stapedectomy: - acoustic neuroma in the ear; . superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease; telangiectasia/hemangioma of larynx, pharynx and trachea (includes ● uvula, palatal or upper lateral pharyngeal tissue); cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal ● fold motion impairment), and cordal lesions of larynx, pharynx and trachea; - myringotomy/tympanostomy (tympanic membrane fenestration); - uvulopalatoplasty (LAUP, laser UPPP); - turbinectomy and turbinate reduction/ablation; - septal spur ablation/reduction and septoplasty; ● - partial glossectomy; - tumor resection on oral, subfacial and neck tissues; - rhinophyma: - verrucae vulgares (warts); ● - gingivoplasty/gingivoctomy. Gynecology (GYN) Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), ● vulvar and vaginal intraepithelial neoplasia (VIN, VAIN); condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; - . incision and drainage (I&D) of Bartholin's and nubuthian cysts; - benign and malignant tumors; - hemangiomas. GYN Laparoscopy Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of: - endometrial lesions, including ablation of endometriosis; ● - excision/lysis of adhesions; ● - salpingostomy - oophorectomy/ovariectomy: ● - fimbrioplasty; - metroplasty; - microsurgery (tubal); - uterine myomas and fibroids; - ovarian fibromas and follicle cysts: ● - uterosacral ligament ablation; - hysterectomy. Neurosurgery Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of: Cranial - posterior fossa tumors; - peripheral neurectomy; ● - benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including ● basal tumors), acoustic neuromas, lipomas and large tumors); - arteriovenous malformation; - pituitary gland tumors (transphenoidal approach). . Spinal Cord incision/excision and vaporization of benign and malignant tumors and ● cysts: - intra- and extradural lesions; - laminectomy/ laminotomy/ microdiscectomy. ● Orthopedics Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy . - menisectomy; - chondromalacia; - . chondroplasty: - ligament release (lateral and other); - excision of plica; ● - partial synovectomy. General - debridement of traumatic wounds; ● - debridement of decubitus and diabetic ulcers; ● - microsurgery; - artificial joint revision; ● - PMMA removal. General/Thoracic Surgery Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include: - debridement of decubitus ulcers, stasis, diabetic and other ulcers; ● - mastectomy; - debridement of bums; - rectal and anal hemorrhoidectomy; - breast biopsy; - reduction mammoplasty; - cytoreduction for metastatic disease; - . laparotomy and laparoscopic applications; - mediastinal and thoracic lesions and abnormalities: ● - skin tag vaporization; - atheroma: - cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; - pilonidal cyst removal and repair; - abscesses; - other soft tissue applications. Dental/Oral Surgery Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include: - gingivectomy- removal of hyperplasias; - . qinqivoplasty: - incisional and excisional biopsy; - incision of infection when used with antibiotic therapy; ● - frenectomy (frenum release); - excision and ablation of benign and malignant lesions: ● - homeostasis; - operculectomy; - crown lengthening: - removal of soft tissue, cysts and tumors; - . oral cavity tumors and hemangiomas: - abscesses: - extraction site hemostasis; - salivary gland pathologies; - preprosthetic gum preparation; ● - . partial glossectomy; - periodontal gum resection. Genitourinary Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include: - benign and malignant lesions of external genitalia; ● - condyloma; ● - Phimosis: - Erythroplasia.

The Syneron CO2RE is a computer controlled radio-frequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The Syneron CO>RE is comprised of multiple components, including the control unit and three handpieces (standard, fractional and surgical). Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.

The eTwo Skin Treatment System is intended for dermatological procedures. The Sublative RF applicator is indicated for dermatological procedures requiring ablation and resurfacing of the skin, and for the treatment of facial wrinkles. At higher energy levels greater than 62 mJ/pin, the Sublative RF applicator is limited to skin types I-IV. The Sublime applicator is indicated for non-invasive wrinkles treatment. At higher energy levels greater than 100 J/cm², the Sublime applicator is limited to skin types I-IV.

The eTwo Skin Treatment System is a mobile system combining two existing technologies and applications for dermatological procedures. The Sublative RF applicator delivers bipolar radiofrequency (RF) to the skin surface via an array of multi-electrode pin tips. The applicator delivers bipolar RF energy to the skin, which results in heating of demarcated spots of skin to temperatures that result in ablation and resurfacing of the skin that comes in contact with the multi-electrode pins. The Sublime applicator uses a combination of an infrared (IR) light source and bipolar radiofrequency (RF) to bulk heat the dermis and affect dermal collagen in order to treat wrinkles. The bulk heating of the dermal layers refers to the gradual and gentle accumulation of heat with each additional pass performed.

The UltraShape System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.

The UltraShape System is comprised of multiple components, including the control unit and two ultrasonic transducers. The UltraShape System selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the UltraShape System achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle. The purpose of this submission is to increase acoustic intensity and to add an additional smaller ultrasound transducer.

The Contour I V3.1 System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.

The Contour I is comprised of multiple components, including the control unit and ultrasonic transducer. The Contour I V3.1 selectively targets subcutaneous adipose tissue via focused ultrasound for the purpose of non-invasive aesthetic body contouring. The transducer is an electro-mechanical device that converts an electrical signal into mechanical (acoustical) energy. The operating parameters of the Contour I achieve selective disruption of adipose tissue without damaging neighboring tissues such as blood vessels, nerves, or muscle.

The Transcend is indicated for temporary reduction in circumference of the abdomen.

The Syneron Transcend is an optical energy in the Infra Red range and a radio frequency of 1 MHz powered system. The device consists of a console and two applicators that deliver electromagnetic energy (IR light and Radio Frequency) and vacuum to treated tissue for the temporary reduction in circumference of the abdomen. The Transcend console includes a control panel, power supply modules, vacuum pump, main Digital Signal Processor, umbilical cable and an adaptor- for connecting the two available applicators, two applicators and two LCD touch-screens.