AcuPulse CO2 Laser System, Delivery Devices and Accessories

The Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry. The intended use of the Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories, is for the performance of specific surgical applications in the surgical specialties of ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry as follows: Dermatology The Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for use in dermatology and plastic surgery for the following applications: Ablation, vaporization, excision, incision and coagulation of soft tissue 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 fine lines and texture irregularities). Laser skin resurfacing (ablation, and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: - Keratosis, including actinic and seborrheic keratosis, seborrhoea vulgares, seborrheic wart and verruca seborrheica. - Vermillionectomy of the lip - Cutaneous horns - Solar/actinic elastosis - Cheilitis, including actinic cheilitis - 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 telangiectaticum) - 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 and partial nail matrixectomy Vaporization or coagulation of: - Benign/malignant vascular/avascular skin lesions - Moh's surgery - Lipectomy - Verrucae and seborrhoecae vulgares, including paronychial, periungal and subungual 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 Th

The Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories, is indicated for the vaporization, incision, excision, ablation or photocoagulation of soft tissue in the surgical specialties of: ENT, Gynecology, Laparoscopic Surgery including GYN Laparoscopy, Aesthetic Surgery, Dental and Oral Surgery, Neurosurgery, Orthopedics, General Surgery and Podiatry.

The Lumenis AcuPulse CO2 Laser System, Delivery Devices and Accessories, is a laser system indicated for various surgical applications. Performance data includes design verification processes following a risk assessment, electrical and laser safety testing, and compatibility testing with existing standards. The system includes the FemX handpiece and is compatible with the AcuPulse W system.