Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories

The Alma Lasers ThermoXELTM CO 2 Laser System and Delivery Device Accessories are intended 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 Alma Lasers ThermoXELTM CO 2 Laser System is cleared for use for the particular indications as follows:

Dermatololiy & 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 bum 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 CO 2 laser increases the amount of sub-epidermal collagen.

Dermatolo2y & Plastic Suriiery, continued

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;

Dermatolojy & Plastic Surgery. continued

* 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;

* Moh's Surgery;

* Lipectomy;

* Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungaual 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.

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

Otolaryngology (ENT)

Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the 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;

Otolaryniology (ENT), continued

* laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;

* Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodivertuculostomy (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 nondularis 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;

* verrmcae vulgares (warts);

* gingivoplasty/gingivoctomy.

Gynecolog¥ (GYN)

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

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

* condyloma acuminate, 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;

GYN Laparoscopy, continued

* ovarian fibromas and follicle cysts;

* uterosacral ligament ablation;

* hysterectomy.

Neurosurgery

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

Cranial

* posterior fossa tumors;

* peripheral neurectomy;

* benign and malignant tumors and cysts (e.g. gliomas, menigiomas (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 and of soft tissue in orthopedic surgery. Applications include:

Arthroscopy

* menisectomy;

* chodromalacia;

* chondroplasty;

* ligament release (lateral and other);

* excision of plica;

* partial synovectomy.

General

* deridement of traumatic wounds;

* debridement of decubitus and diabetic ulcers;

* microsurgery;

* artificial joint revision;

* PMMA removal.

General/Thoracic Surgery

Incision, excision and vaporization and 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 bums;

* rectal and anal hemorrhoidectomy;

* breast biopsy;

General/Thoracic Surgery, continued

* 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;

* homeostasis;

* operculectomy;

* crown lengthening;

Dental/Oral Surgery, continued

* 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 and of soft tissue in genitourinary procedures. Applications include:

* benign and malignant lesions of external genitalia;

* condyloma;

* phimosis

* 'erythroplasia.

The Alma Lasers ThermoXELTM CO 2 Laser System Pixel Handpieces are indicated for use in soft tissue for:

Dermatoloey & Plastic Surgery

* Skin resurfacing