(63 days)
The Modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (members of the UltraPulse CO2 Laser Systems Family) is indicated for use in surgical or aesthetic applications requiring:
ablation, vaporization, excision, or coagulation of soft tissue in medical specialties including; dermatology and plastic surgery (aesthetic), podiatry, gyneoology, general and thoracic surgery, 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).
- -Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- · Keratoses, including actinic and sebortheic keratosis, sebortheic wart and verruca sebortheica.
- · 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 granuloma pyogenicum/granuloma telangiectaticum)
- 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 or coagulation of:
- · Benign and malignant vascular/avascular skin lesions
- · Moh's Surgery
- Lipectomy
- · Verrucae and seborrhoecae 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
- Porokeratoma ablation
- · Ingrown nail treatment
- Neuromas/fibromas, including Morton's neuroma
- Debridement of ulcers
- Other soft tissue lesions
Laser ablation, vaporization, and/or excision for complete and partial matrixectomy
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
- · vulvar and vaginal intraepithelial neoplasia (VIN, VAIN)
- · Condyloma acuminata, including genital, vulvar, perineal, and Bowen's disease (Erythrolasia 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
- Benign and malignant tumors
- · Hemangiomas
General Surgery
- Debridement of traumatic wounds
- Debridement of decubitus and diabetic ulcers
- · Microsurgery
- · Artificial joint revision
- PMMA removal
General and 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 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 and 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
- · 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
The Lumenis Be modified ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories when used in conjunction with FemTouch and FemX, is indicated for the vaporization, ablation and coagulation of body soft tissue in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, gynecology, general and thoracic surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.