The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch

The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The UltraPulse system is indicated for use in the performance of specific surgical applications in these specialties as follows: 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 derm-abrasion • Laser burn debridement - Laser skin resurfacing (ablation and/or vaporization) for 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: • Keratoses, including actinic and seborrheic keratosis, seborrhoecae 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 and 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 - Laser ablation, vaporization, and/or excision of soft tissue for the reduction, re

The UltraPulse system (UltraPulse and UltraPulse DUO models, members of the modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers) is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.

The UltraPulse System, subject of this submission, is a carbon dioxide laser system based on a Radio Frequency (RF) modulated CO2 laser tube. It is a new member of the UltraPulse SurgiTouch Family of CO2 Laser Systems, Delivery Devices and Accessories, previously cleared under K030147 and manufactured by Lumenis. The UltraPulse System relies on the same fundamental underlying technology of the cleared systems with some modifications as compared to the cleared family members. The UltraPulse System, subject of this submission, includes two models: the UltraPulse and the UltraPulse DUO. The UltraPulse model delivers laser energy via a Free Beam Port to which an articulated arm and accessories are connected, similarly to the cleared UltraPulse SurgiTouch CO2 Laser Systems (K030147). The UltraPulse DUO model incorporates also a Fiber Port to which a Fiber and accessories are connected, in addition to the Free Beam Port. Both models of the UltraPulse System, subject of this submission, as well as its cleared UltraPulse SurgiTouch family (K030147), are comprised of the following main components: a Laser Console with a Free Beam Port to which a counterbalanced articulated arm is attached, a Footswitch or Handswitch, a variety of Delivery Device accessories or handpieces, including a scanning pattern generator. The UltraPulse DUO model includes also the following functional elements: a Fiber Port (on the Laser Console) to which a Fiber is attached, a variety of Delivery Device accessories or handpieces, including a Fiber Support Arm and Fiber Handpiece Support Arm. The UltraPulse System (both models) is operated and controlled via proprietary SW embedded in the Main controller, Peripheral controller units and PC.