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EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. GENERAL SURGERY, DERMATOLOGY & PLASTIC SURGERY, AND PODIATRY: excision, ablation, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion. GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue. NEUROSURGERY: Hemostasis. OPHTHALMOLOGY: Incision, excision and vaporization of tissue surrounding the eye and orbit; Photocoagulation of the retina. PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue. UROLOGY: Hemostasis, vaporization and excision of tissues.

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EAR, NOSE AND THROAT AND ORAL SURGERY: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples: - Removal of benign lesions from the ear, nose and throat - Excision and vaporization of vocal cord nodules and polyps - Incision and excision of carcinoma in-situ - Ablation and vaporization of hyperkeratosis - Excision of carcinoma of the larynx - Laryngeal papillomectomy - Excision and vaporization of Herpes Simplex I and II - Pulpotomy and pulpotomy as an adjunct to root canal therapy - Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) ARTHROSCOPY: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples: - Meniscectomy - Synovectomy - Chondromalacia GASTROENTEROLOGY: Hemostasis, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples: - Hemostasis of upper and lower GI bleeding - Excision and vaporization of colorectal carcinoma - Excision of polyps GENERAL SURGERY, DERMATOLOGY & PLASTIC SURGERY, AND PODIATRY: excision, ablation, and vaporization of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissues, and dermabrasion. Examples: - Matrixectomy - Excision of neuromas - Excision of periungual & subungual warts - Port wine stain removal - Excision of plantar warts - Excision of keloids - Cholecystectomy - Liver resection - Excision of cutaneous lesions - Hemorrhoidectomy - Appendectomy - Debridement of decubitus ulcer - Hepatobiliary - Mastectomy - Dermabrasion - Vaporization & hemostasis of capillary hemangioma - Excision, vaporization & hemostasis of abdominal tumors - Excision, vaporization & hemostasis or rectal pathology - Pilondial cystectomy - Herniorrhaphy - Adhesiolysis - Parathyroidectomy - Laparoscopic cholecystectomy - Thyroidectomy - Resection of organs GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples: - Hemorrhoidectomy - Excision, vaporization and hemostasis of rectal pathology - Excision, vaporization, and hemostasis of abdominal tumors GYNECOLOGY: ablation, excision, hemostasis and vaporization of tissue. Examples: - Endometrial ablation - Excision or vaporization of condylomata acuminata - Vaporization of CIN (cervical intraepithelelial neoplasis) - Cervical conization - Menorrhagia NEUROSURGERY: - Hemostasis - Hemostasis for myangioma OPHTHALMOLOGY: - Incision, excision and vaporization of tissue surrounding the eye and orbit - Photocoagulation of the retina PULMONARY SURGERY: Hemostasis, vaporization, and excision of tissue. Examples: - Tracheobronchial malignancy or stricture - Benign and malignant pulmonary obstruction UROLOGY: Hemostasis, vaporization and excision of tissues. Examples: - Vaporization of urethral tumors - Release of urethral stricture - Removal of bladder neck obstruction - Excision and vaporization of condyloma - Lesions of external genitalia

Aurora™ HL Diode Laser System

Curing of all light cured bonding materials Curing of pit and fissure sealants (unfilled resins) Curing for all classes of composite restorations (filled resins) Curing for endodontic composite cores Curing composite cements for porcelain facings and inlays Curing of light activated periodontal splint material Curing of light activated prosthetic reline and repair material Curing use in the fabrication of laboratory indirect light activated and provisional restorations Teeth Whitening

BluLaze™ Blue Light Emitting Diode (LED) System

Pulpotomy Pulpotomy as an adjunct to root canal therapy This is an additional indication to the indications cleared for market NOTE: Release in 510(k) 954316.

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The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Enamel prior to acidentify, and Modification or Etching of Dentin prior to acid etching.

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Pulpotomy; Pulpotomy as an adjunct to root canal therapy

Pegasus Nd: YAG Laser System

(SULCULAR DEBRIDEMENT) - REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET. NOTE: This is an additional indication to the indications cleared for market release in 510(k) 954316.

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Scanning device attachment used with the Centauri™ Er:YAG Laser System for use in Dermatology for treatment of soft tissue, including incision, excision, hemostasis, ablation and vaporization of tissue.

Scanning device attachment used with the Centauri™ Er:YAG Laser System

1. Curing of all light cured bonding materials. 2. Curing of pit and fissure sealants (unfilled resins). 3. Curing for all classes of composite restorations (filled resins). 4. Curing for endodontic composite cores. 5. Curing composite cements for porcelain facings and inlays. 6. Curing of light activated periodontal splint material. 7. Curing of light activated prosthetic reline and repair material. 8. Curing used in the fabrication of laboratory indirect light activated restorations and provisional restorations. 9. Illumination purposes for the adjunctive use in caries detection. 10. Illumination purposes for the adjunctive use for endodontic orifice location. 11. Light activation for bleaching materials for teeth whitening.

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The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Enamel prior to acid etching, and Modification or Etching of Dentin prior to acid etching.

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