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The LightScalpel LS-2010 SX, LS-2010 DX CO2 Laser Systems are intended for use intended for use in laser surgery procedures for incision, excision, vaporization, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, orthopedic surgery, neurosurgery, podiatry, and urology. Intended uses specific to the LS-2010 FX and LS-2010 DX in fractional mode are indicated by **. Dermatology / Plastic Surgery: Ablation, and Vaporization of soft tissue for performance of or treatment of: laser dermabrasion: laser burn debridement; wrinkles*, and furrows**; textural irregularities**; vascular dyschromia**; and benign pigmented lesions ** Intended uses specific to the LS-2010 SX and LS-2010 DX in surgical mode are listed below. Dental Surgery: Gingivectomy - Removal of hyperplasias; gingivoplasty; papillectomy; vestibuloplasty; epulis; sulcular debridement; removal of soft tissue, cysts, and fibroma (non-malignant tumor, mucosa, tongue); extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; a heat source to activate tooth bleaching materials: Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium). Oral Surgery: Frenum release/frenectomy; abscess (drainage); flap surgery; biopsy (incisional); aphthous ulcers (incision & excision); excision & ablation of lesions, benign lesions, oral cavity tumors, and hemangiomas; salivary gland pathologies; preprosthetic gum preparation, leukoplakia; partial glossectomy; periodontal gum resection; homeostasis; operculectomy; crown lengthening (soft tissue); incision when used with antibiotic therapy. General and Thoracic Surgery: Incision, excision, and vaporization of soft tissue in general and thoracic surgery, including endoscopic and open procedures for: debridement of decubitus ulcers, stasis, diabetic, and other ulcers; mastectomy; debridement of burns; rectal and anal hemorrhoidectorny; 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 and pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair: abscesses; other soft tissue applications. Dermatology / Plastic Surgery: Incision, Excision, Ablation, and Vaporization of soft tissue for performance of or treatment of: laser skin resurfacing: laser dermabrasion; laser burn debridement; wrinkles, rhytids, and furrows; textural irregularities; keratosis, including actinic and sebortheic keratosis, sebortheci wart, and verruca seborrheica; vermillionecomy of the lip; cutaneous horns; solar/actinic elastosis; cheilitis; including actinic cheilitis; lentigines, including lentigo maligna or Hutchinson's freckle; uneven pigmentation/vascular dyschromia;; surgical scars; keloids, including acne keloidalis nuchae; hemangiomas, including Buccal, port wine, and pyogenic granuloma, pyogenicum/granuloma telagiectatioum; tattoos; telangiectasias; removal of small skin tumors, including periungual (Koenen) and subungual fibromas; benign pigmented lesions; adenosebaceous hypertrophy or sebaceous hyperplasia; thinophyma reduction; cutaneous papilloma (skin tags); milia; debridement of eczematous or infected skin; basal & 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-epitheliomas; xanthelasma palpebrarum; syringoma; complete or partial natrixectomy; benign vascular/avascular skin lesions; Mohs surgery; lipectomy; verrucae and seborrhoecae vulgares, including; paronychial, periungual warts; blepharoplasty; and hair transplantation site preparation. Gynecology / Genitourinary: Incision, excision, ablation, and/or vaporization of soft tissue for treatment of: Conization of the cervix, including cervical intraepithelial neoplasia and vulvar and vaginal intraepithelial neoplasia; Condyloma, including cervical, genital, vulvar, perineal, and Bowenoid papulosa; leukoplakia (vulvar dystrophies); incision and drainage of Bartholin's and nabothian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; benign tumors; hemangiomas; benign lesions of external genitalia; condyloma; phimosis; erythroplasia. Gyn Laparoscopic Surgery: Laser incision, excision, vaporization, and photocoagulation of soft tissue for treatment of: endometrial lesions, including ablation for endometriosis; excision/lysis of adhesions; salpingotomy; oophorectomy; fimbrioplasty; metroplasty; uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy. Otorhinolaryngology / ENT: Laser incision, excision, ablation, vaporization, and / or photocoagulation of soft tissue in otorhinolaryngology for treatment of: leukoplakia, including oral, larynx, uvula, palatal, and upper lateral pharyngeal tissue; adult and juvenile papillomatosis polyps; lymphangioma removal; removal of recurrent papillomas in the oral cavity, larynx, pharynx, and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue, and vocal cords; stenosis, including subglottic stenosis; tonsiller cryptolysis and neoplasma) and topsil ablation / tonsillotomy; benign tumors and fibromas (oral); superficial lesions of the ear, including chondrodermatits nondularis chronica helices / Winkler's disease; uvulopalatoplasty (LAUP, laser UPPP); turbinate reduction / ablation; septal spur ablation/reduction. and septoplasty; partial glossectomy; tumor resection of oral, subfacial, and neck tissues; rhinophyma; verrucae vulgares (warts); gingivoplasty / gingivectomy Podiatry: Laser excision, ablation, and /or vaporization of soft tissue in podiatry for the reduction, removal and/or treatment of: Verrucae vulgares / plantar warts, including paronychial, periungual warts; fungal nail treatment: matrixectomy - partial and complete; porokeratoma ablation; neuromas/fibromas, including Morton's neuroma removal; ingrown toenail treatment; debridement of ulcers; treatment of other soft tissue lesions Orthopedic Surgery: Laser incision / excision, ablation, and /or vaporization of soft tissue in orthopedic surgery. Applications include: meniscectorny; chondromalacia ablation; chondroplasty; ligament release (lateral and other); excision of plica; partial synovectomy; debridement of traumatic wounds; debridement of decubitus & diabetic ulcers; and PMMA removal. Neurosurgery: Laser incision / excision, ablation, and /or vaporization of soft tissue in neurosurgery for the treatment of: posterior fossa tumors; peripheral neurectomy; benign tumors and cysts (e.g. gliomas, meningiomas (including basal tumors), acoustic neuromas, lipomas, and large tumors); arteriovenous malformation; and pituitary gland tumors (transphenoidal approach).

The LightScalpel LS-2010 SX, LS-2010 FX, and LS-2010 DX laser systems are mobile platforms that utilize a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength. Output parameters are summarized in Table 1. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. A "calibration port" on the side of the laser systems allows checking and setting the power emitted from the distal laser aperture to the internal power meter and serves as a check on fiber waveguide transmission efficiency. Laser system power, rates, and durations are adjustable as tabulated below (7): The laser systems have safety features complying with requirements in 21 CFR 1040. Performance Standards for Light Emitting Products. Primary safety features are as follows: System On-Off Keyswitch, Emergency Stop Switch, Remote Interlock, Fiber Interlock, Beam Blocking Shutter, Internal Laser Power Detector, RF Power Monitor, and required Laser Safety Labels and Labeling. Laser system physical characteristics are: Delivery System: LS-2010 SX, Flexible Fiber Waveguide; ~ 0.75mm ID, Handpieces with internal focusing lens ("tipless") and with disposable pre-sterilized ceramic tips. LS-2010 FX & DX; Flexible Fiber Waveguide; ~ 0.50mm ID, Handpiece with internal beam steering galvanometers and laser diode aiming beam. Purge Gas: Internal air pump purge through the Fiber and Handpiece. System Cooling: Air; two thermostatically controlled fans with over-temperature protection. Mobility: 4 wheels and handgrip on console for convenient system positioning.

The LightScalpel LS-1005 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, podiatry, and urology. Dental Procedures: Gingivectomy - Removal of hyperplasias; Gingivoplasty; Papillectomy; Vestibuloplasty; Epulis: Sulcular Debridement; Removal of soft tissue, cysts, and fibroma (non-malignant turnor, mucosa, tongue); Extraction site hemostasis; treatment of ulcerous lesions, including aphthous ulcers; A heat source to activate tooth bleaching materials; Laser Assisted New Attachment Procedure (cementum-mediated periodontal ligament new attachment to the root surface in the absence of long junctional epithelium). Oral Surgery Procedures: Frenum Release/Frenectomy; Drainage (abscess); Flap Surgery; Biopsy (incisional & excisional); Aphthous Ulcers (incision & excision); Incision of Infection when used with antibiotic therapy; Excision & Ablation of lesions, benign & malignant lesions, oral cavity turnors, and hemangiomas; Salivary Gland Pathologies; Preprosthetic Gum Preparation, Leukoplakia; Partial Glossectomy; Periodontial Gum Resection; Homeostasis; Operculectorny; Crown Lengthening (soft tissue).

The LightScalpel LS-1005 laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.

The LightScalpel LS-10 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, plastic & reconstructive surgery, podiatry, and urology.

The LightScalpel LS-10 laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO₂) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.

Intended use is to communicate the laser beam of a CO2 surgical laser to the target site for the incision, excision, ablation, or photocoagulation of soft tissue. Representative examples of indications for use: Gynecology-excision and vaporization of cervical, vulvar, and perineal condyloma; ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization; vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts. Dermatology – port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratosis, actinic keratosis and actinic cheilitis. Dentistry/Oral Surgery – gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors General Surgery - hemorrhoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of deciditus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cyto-reduction for metastatic disease; many dermatological procedures. Laparoscopic surgery – vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy. Otorhinolaryngology - lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsillectomy, removal of vocal cord papillomas, nodules, and polyps. Podiatry – plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neuroma removal; ingrown toenail treatment Orthopedic - menisectomy, chondromalacia ablation, partial synovectomy, lateral release, PMMA removal

These tips are short, hollow lightpipes of alumina ceramic or stainless steel that provide a variety of spot sizes to target tissue when utilized in a mating laser handpiece.