Alma Lasers Pixel CO2 Laser System, Delivery Device and Accessories

The Alma Lasers Pixel CO2TM Laser System, Delivery Devices and 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 Pixel CO2TM Laser System is cleared for use for the particular indications 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 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 CO2

laser increases the amount of sub-epidermal collagen.

Dermatologyv & Plastic Surgery, 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/actinie elastosis;

* chelitis, including actinic chelitis;

* lentigines, including lentigo rnaligna 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 squamnous cell carcinoma, including keratoacanthomas, Bowen's disease

(Erythroplasia of Queyrat), and lBowenoid Papulosis (B3P) lesions;

Dermatologly & Plastic Surg~ery, continued

" nevi, including spider, epidermal and protruding;

* neurofibromas;

* laser de-epithelialization;

* tricoepitheliomnas;

" xanthelasma palpebrarurn;

" syringoma

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

Vaporization/coagulation of:

* benign/malignant vascular/avascular skin lesions;

* Mob'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;

* porokeratomna 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,uppeateraphaiyngealiissue;---.. -

* nasal obstruction;

" adult and juvenile papillomnatosis polyps;

* polypectomy of nose and nasal passages;

* lympliangiomna removal;

" removal of vocal cord/fold nodules, polyps and cysts;

* removal of recurrent papitlomnas in the oral cavity, nasal cavity, larynx, pharynx and

trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal

cords;

Otolaryngology (ENT), continued

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

* Zenker's Diver-ticuiluin/pharyngoesophagea diverticulumi [endoscopic laser-assisted

esophagodivertuculostomny (ELAEO)];

* 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,

tracheobronch ial/endobronch ial);

* benign and malignant lesions and fibromas (nose and nasal passages);

* benign and malignant tumors and fibromas; (oral);

* stapedotomy/stapedlectomy;

* 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 IJPPP);

* 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/gingivoctomy.

Gynecology (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;

e leukoplakia (vulvar dystrophies);

¢ incision and drainage (1&D) of Bartholin’s and nubuthian cysts;

e 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:

e endometrial lesions, including ablation of endometriosis;

e excision/lysis of adhesions;

® salpingostomy;

® oophorectomy/ovariectomy;

e fimbroplasty;

® metroplasty;

® microsurgery (tubal);

e uterine myomas and fibroids;

GYN Lanaroscopy. continued

* ovarian fibromas and follicle cysts;

* uterosacral ligament ablation;

" hysterectomy.

NeurosurgerV

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;

0 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 pleca;

*partial synovectomy.

General

* deridement of traumatic wounds;

* debridlement of decubitus and diabetic ulcers;

*microsurgery;

*artificial joint revision;

*PMIMA 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 burns;

* rectal and anal hemorrhoidectomy;

* breast biopsy;

General/Tlioracic Surilery, continued

* reduction mammoplasty;

* cytoreductibn f'or metastatic disease;

* laparotomy and laparoscopic applicaions;

" 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 Sur2erV. 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;

* condylomna;

* phimosis

" erythroplasia.