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The Alma FemiLift Pixel CO2 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 FemiLift Pixel CO2 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 dermabrasion
• 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.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:

• Keratoses, including actinic and seborrheic keratosis, seborrheic vulgaris, seborrheic wart, and verruca seborrhoica;
• Vermilionectomy 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;
• Aden sebaceous 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;
• Trichoepitheliomas;
• 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 seborrheic vulgaris, including paronychial, perifungal, 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 vulgaris/plantar (warts), including paronychial, perifungal, 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;
• Laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structure and tissue
• Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophageal diverticulectomy (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, subfascial and neck tissues;
• Rhinophyma;
• Verrucae vulgaris (warts);
• Gingivoplasty/gingivectomy.

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 papulosis (BP) lesions;
• Leukoplakia (vulvar dystrophies);
• Incision and drainage (I&D) of Bartholin's and Nabothian 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;
• Fimbrioplasty;
• Metroplasty;
• Microsurgery (tubal);
• Uterine myomas and fibroids;
• 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, meningiomas (including basal tumors), acoustic neuromas, lipomas and large tumors);
• Arteriovenous malformation;
• Pituitary gland tumors (transsphenoidal 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

• Meniscectomy;
• 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 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;
• 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 hyperplasia;
• 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;
• Pre-prosthetic 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 FemiLift Pixel CO2 System is a laser system designed to deliver light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissues in various medical specialties. The system consists of the following major components:

• Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel)
• Control panel with touch-screen technology
• Articulated arm
• Footswitch
• Delivery device handpieces, including:
  • Focusing handpieces (FemiLift-Subject Device, CO2 Focus 50mm, and CO2 Focus 100mm)
  • Pixel handpieces (CO2 Pixel 7x7 and CO2 Pixel 9x9),
  • Scanning handpiece

The FemiLift Handpiece is a 50mm focusing handpiece that has been added to the existing suite of handpieces previously cleared under K103501. The FemiLift Handpiece is comprised of a reusable handpiece body and a sterile sleeve ("FemiLift Single-Use Sleeve"). The handpiece body connects to the laser system and directs the laser beam for treatment, using a mirror to deflect the laser beam by 90°. The FemiLift Single-Use Sleeve provides a sterile barrier between the handpiece body and the patient.

The Alma FemiLift Pixel CO2 System can be used with the CO2 Focus 50mm and 100mm Handpieces, CO2 Pixel 7x7 and 9x9 Handpieces, and CO2 Scanner Handpiece for all of the specific uses indicated for the system, and with the FemiLift Handpiece for the gynecology and aesthetic surgery (dermatology and plastic surgery) indications.

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