Evolve (R) HPD 980/1470NM Multiwavelength Diode Laser

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 Evolve HPD Multiwavelength 980/1470 Diode Laser (up to 150W) 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, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the saphenous veins in patients with superficial vein reflux. The Multiwavelength laser is further indicated for laser assisted lipolysis. Power from 15 1W to 200W is indicated in the vaporization of the prostate to treat Benign Prostatic 1-yperplasia (BPH).

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 and 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 debulldng 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

Laser Assisted Lipolysis

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

Endovenous Occlusion of the Saphenous Veins in Patients with Superficial Vein Reflux Associated with Varicose Veins and Varicosities

Treatment of reticular veins and branch varicosities

Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues.

Examples include:

Vaporization of urethral tumors

Release of urethral stricture

Removal of bladder neck obstruction

Excision and vaporization of condyloma

Lesions of external genitalia

Vaporization of the prostate to treat benign prostatic hyperplasia (SPIT). Note: powers from 15 1W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic Hyperplasia (BPH).

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue.

Examples include:

Endometrial ablation

Excision or vaporization of condylomata acumninate

Vaporization of cervical intraepithelial neoplasia

Cervical conization

Menorrhagia

Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue.

Examples include:

hemostasis 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, operculectomy, implant recovery, gingivectomy, 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, papillectomy, vestibuloplasy, 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.

Powers from 151W to 200W

Powers from 15 1W to 200W should only be applied in the vaporization of the prostate to treat Benign Prostatic 1-yperplasia (BP-).