ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories

The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring:

ablation, vaporization, excision, incision, or coagulation of soft tissue in medical specialties including: dermatology and plastic surgery (aesthetic), podiatry, gynecology, general and thoracic surgery, dental and oral surgery and genitourinary surgery 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

• N eurofibromas

• 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, removal, and/or treatment of:

* Verrucae vulgares/plantar (warts), including paronychial, periungal and subungual warts

* Porokeratoma ablation

* Ingrown nail treatment

* Neuromas/fibromas, including Morton’s neuroma

* Debridement of ulcers

* Other soft tissue lesions

Laser ablation, vaporization, and/or excision for complete and partial matrixectomy

Gynecology (GYN)

Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:

* vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)

* Condyloma acuminata, including genital, vulvar, perineal, and Bowen’s disease (Erythrolasia of Queyrat) and Bowenoid papulosa (BP) lesions

* Leukoplakia (vulvar dystrophies)

* Incision and drainage (1&D) of Bartholin’s and nubuthian cysts

* Herpes vaporization

* Urethral caruncle vaporization

* Benign and malignant tumors

* Hemangiomas

General Surgery

Debridement of traumatic wounds

Debridement of decubitus and diabetic ulcers

* Microsurgery

* Artificial joint revision

* PMMA removal

General and Thoracic Surgery

Incision, excision and vaporization 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 burns

* Rectal and anal hemorrhoidectomy

* Breast biopsy

* Reduction mammoplasty

* Cytoreduction for metastatic disease

* Laparotomy 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 and Oral Surgery

Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:

* Gingivectomy/removal of hyperplasias

* Gingivoplasty

* Incisional and excisional biopsy

* Treatment of ulcerous lesions, including aphthous ulcers

* 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

* Leukoplakia

* Partial glossectomy

* Periodontal gum resection

Genitourinary

Incision/excision and vaporization of soft tissue in genitourinary procedures. Applications include:

* Benign and malignant lesions of external genitalia

* Condyloma

* Phimosis

* Erythroplasia

The Lumenis Be modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, incision, excision, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, gynecology, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.