Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories

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)

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 telangiectaticum);
• 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 Mor

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 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.