CO2RE System

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 CO2RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin. The Standard Handpiece of the CO2RE System is indicated for the following: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, 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 lines 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; - syringoma. Laser ablation, vaporization and/or 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 le

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 CO2RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin. The Standard Handpiece of the CO2RE System is indicated for the following: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, 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 lines 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; syringoma. Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of: benign/malignant vascular/avascular skin lesions; Verrucae and seborrhoecae vulgares,

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 CO2RE 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 Syneron CO2RE technological characteristics are very similar to those of the predicate devices.