Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers

The Modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are 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 Modified Lumenis Family of UltraPulse SurgiTouch CO2 Surgical Lasers are indicated for use in the performance of specific surgical applications in 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 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).

Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the UltraPulse 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;

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 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 and partial nail matrixectomy.

Vaporization/coagulation of:

benign/malignant vascular/avascular skin lesions;

Moh's Surgery;

lipectomy;

verrucae and seborrheocae 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;

fungal nail treatment;

porokeratoma ablation;

ingrown nail treatment;

neuromas/fibromas, including Morton's neuroma;

debridement of ulcers;

other soft tissue lesions.

Otolaryngology (ENT)

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

choanal atresia;

leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue;

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 esophagodiverticulostomy (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/gingivectomy.

Gynecology (GYN)

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

conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);

condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen’s disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;

leukoplakia (vulvar dystrophies);

incision and drainage (I&D) of Bartholin’s and nubuthian cysts;

herpes vaporization;

urethral caruncle vaporization;

cervical dysplasia;

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;

fimbroplasty;

metroplasty;

microsurgery (tubal);

uterine myomas and fibroids;

ovarian fibromas and follicle cysts;

uterosacral ligament ablation;

hysterectomy.

Neurosurgery

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

Cranial

posterior fossa tumors;

peripheral neurectomy;

benign and malignant tumors and cysts (e.g. gliomas, meningiomas (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 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 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 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;

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;

hemostasis;

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.