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The Vectra Family of Laser Systems and Accessories are indicated for ablation, vaporization, coagulation, incision/excision of soft tissue in contact or non-contact mode including open surgery and via endoscopes, introducers, trocars, or catheters. The Vectra Family of Laser Systems and Accessories are indicated for use in surgical procedures on skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands in surgical specialties including but not limited to genitourinary surgery, urology (including BPH), gynecology (GYN), gastroenterology, general surgery (including specific treatment of varicose veins, varicosities associated with superficial reflux of the greater saphenous vein, removal of pigmented lesions, photothermolysis of hair follicles), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, podiatry, pulmonary/ thoracic surgery, dentistry and oral surgery (intra/extra oral soft tissue, e.g., removal of diseased soft tissue in the periodontal pocket, and for light activation of bleaching materials for teeth whitening.) The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes. The device is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, genecology, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein.

The Vectra Family of Laser Systems emitting 980nm and 1470 nm wavelengths are substantially equivalent to the Xintec Corporation Vectra Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980nm and 1470nm Diode Laser Systems (East Longmeadow, MA) which have been previously cleared for marketing under applicable 510(k) pre-market notification regulations.

The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscope. The device is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose, and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. The device is specifically indicated for use as follows: Ear, Nose and Throat and Oral Surgery (Otolaryngology) Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include: 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 Neck dissection Arthroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: Menisectomy Synovectomy Chondromalacia Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts an also with endoscopic procedures. Examples include: 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, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcers Hepatobiliary tumors Mastectomy Dermabrasion Vaporization and hemostasis of capillary hemangioma Excision, vaporization and hemostasis of abdominal tumors Excision, vaporization and hemostasis of rectal pathology Pilonidal cystectomy Herniorapphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystectomy Thyroidectomy Resection of organs Debridement of wounds Photocoagulation of teleangectasia of the legs and face Photocoagulation of vascular lesions of the face and extremities Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux Treatment of reticular veins and branch varicosities Urology Excision, vaporization, incision, coagulation, ablation and homeostasis of urological, including BPH/prostatic, tissues. Examples include: Vaporization of uretheral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue. Examples include: Endometrial ablation Excision or vaporization of condylomata acuminate Vaporization of cervical intraepithelial neoplasia Cervical conization Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: Hemeostasis in conjunction with menigiomas Cardiac Surgery Hemostasis and coagulation of soft tissue, including cardiac tissue Pulmonary Surgery Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction Endoscopic pulmonary applications Dental Applications Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectorny, implant recovery, gingivoplasty, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibulopasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening. Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux Indicated for use in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

The Vectra™ Laser System and Accessories is substantially equivalent to the Optica and Odyssey Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980 Diode Laser Systems (East Longmeadow, MA)) previously cleared for marketing under applicable 510(k) pre-market notification regulations. Table I summarizes device specifications of the Vectra Laser Systems compared to the Xintec Corporation Optica and Odyssey Laser Systems (Xintec Corporation, dba, Convergent Laser Technologies, Alameda, CA) and Ceralas D 980 Diode Laser System (East Longmeadow, MA)) which have been previously cleared for marketing under applicable 510(k) pre-market notification regulations.

The Polaris Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dermatology and Plastic Surgery for Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only); Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery; Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.

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The Protégé II Er:YAG Laser Systems and accessories are indicated for the surgical incision/excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, agans and glands. Dentistry: Soft tissue (incision, excision, ablation and coagulation) Dermatology Plastic Surgery: Indications include epidermal nevi, clangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors and cysts, skin resurfacial skin lesions, and performing: diagnostic biopsies. General Surgery: Indications include surgical incision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated. Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrown and uretira (includes condylomaacuminata, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon. Gynecology: Indications include cervical intracoithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Oral Maxillofacial: Indications include benign oral tumor, oral and glossal lesions and gingivectorny. Otorhinolaryigology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue and oral leukoplakia. Ophthe mology: Indications include soft tissue surrounding the eye and orbit and anteriorcapsulotomy. Podiatry: Indications include warts, plantar verrucae, large mosaic verrucae andmatrixectorny. Arthrescopy: Including open and laparoscopic procedures Orthopedic Surgery Thoracic Surgery

Protégé II (tm) Er: YAG Laser System and Accessories (Upgrade)

The Alexis Alexandrite Laser System and accessories are indicated for: Cosmetic and Plastic Surgery Photocoagulation of dermatological vascular lesions Treatment of cutaneous vascular and pigmented lesions

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The Protégé and Protégé LP Er: YAG Laser Systems and accessories are indicated for incision/excision, ablation, and coagulation (hemostasis) of soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, mucous membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dentistry Soft tissue (incision, excision, ablation and coagulation) Dermatology and Plastic Surgery Epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers Oral/Maxillofacial (benign oral tumor, oral and glossal lesions and gingivectomy) Ear Nose & Throat (ENT), Head and Neck Surgery GI, GU, GYN and Pulmonary Surgery Orthopedic Surgery Thoracic Surgery Ophthalmology Podiatry General Surgery

Protégé and Protégé LP Er: YAG Laser Systems and Accessories

The Dentica Pulsed Nd: YAG Laser System and accessories is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue and cartilage. Soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous membrane. Ivmph vessels and nodes, organs and glands. Specific surgical specialties include: Dentistry Laser Curettage; Gingivectomy; Gingivoplasty; Incision and Excision Oral Surgery Frenectomy; Incisional and Excisional Biopsy; Incisional and Excisional aphous ulcers; Incision of infection when used with antibiotic therapy; Excision and ablation of benign and malignant lesions and conditions; Homeostasis; Operculectomy, and Crown lengthening. Ear Nose & Throat (ENT) Head and Neck Surgery Thoracic Surgery Neurology (homeostasis only) Dermatology Plastic Surgery General Surgery

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