Manufacturer
Bio-Med USA, Inc.Cellene CO2 Laser System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K182270
- Device name
- Cellene CO2 Laser System
- Company
- Bio-Med USA, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-08-22
- Decision date
- 2018-11-02
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Cellene CO2 laser system is indicated 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 Cellene CO2 Laser system is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin. The Standard Handpiece of the Cellene CO2 System is indicated for the following: 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 fine 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, seborrhoeic 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 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 or partial nail matrixectomy. Vaporization/coagulation of: benign/malignant vascular/avascular skin lesions; Verrucae and seborrhoeic vulgares, including paronychial, periungal, and subungual wart. Podiatry Laser ablation, vaporization and/or excision of soft tissue for the reduction, removal, and/or treatment of: Verrucae, vulgares/plantars (warts), including paronychial, periungal, and subungual warts, fungal nail treatment, porokeratoma ablation; ingrown nail treatment; neuromas/fibromas, including Morton's neuroma, debridement of ulcers, and other soft tissue lesions. Laser ablation, vaporizat
Intended Use
The Cellene Co2 laser system is indicated 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 Cellene Co2 Laser system is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
Device Description
The Cellene Co2 Laser system is a computer controlled Radio Frequency system that delivers Co2 energy to the target treatment area at 10,600nm wavelength using three different Handpieces (Standard, Fractional and Surgical). This Co2 laser energy is absorbed by water in tissue to achieve its intended treatment effects. The system consists of a laser tube placed in the mixed crystals of copper pipe to the heater, producing a laser beam, and a resonator that amplifies the beam through the Xe-gas contained lamp. The laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed Hand Piece. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using a Foot Switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit. This system also consists of an Optic main Bench assembly, Articulated Arm, 3 Hand pieces, LCD control panel, Cooling system, and Foot Pedal Switch.
Summary parsed at:2026-06-01 05:57:58 UTC
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