Quanta System Polysurge Diode Laser Family

The Quanta System Polysurge Diode Laser Family, including the Polysurge8O8, Polysurge940, Polysurge980, Polysurge1064, Polysurge1320, Polysurge1470 and Polysurge 1950 (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

LASER 808nm and 980nm

Urology:

- Lesions of external genitalia

- Circumcision

- Condyloma

- Bladder tumors

- Bladder neck incisions

- Vaporization of the prostate

General Surgery:

Rectal and anal hemorrhoidectomy

- Mastectomy

- Dermabrasion

- Appendectomy (open and laparscopic)

- Bowel resection (open and laparscopic)

- Colectomy

- Liver resection

- Resection of organs

- Thyriodectomy

- Adhesiolysis

- Hepatobiliary tumors

- Thoracotomy

- Cholecystectomy (open and lapararscopic)

- Condyloma

- Breast biopsy

Neurosurgery:

- Percutaneous Disc Decompression (PLDD)

- Discectomy

- Hemostasis in conjunction with meningiomas

Gynecology:

Cervical conization

Myomectomy

Endometrial ablation

Ovarian cystectomy

Appendectomy

Ophthalmology:

- Dacryocystorhinostomy transcanalicular

- Open DCR

- Tumor excision

- Blepharoplasty

Orthopedics:

- Dissect and coagulate

Gastroenterology:

Hemostasis of colonoscopy

Hemostasis of esophageal varices

Excision of polyps

Arthroscopy:

- Chondromalacia

- Synovectomy

- Menisectomy

Thoracic Surgery:

- Thoracotomy

- Pulmonary resection

- Hemostasis

- Pericardiectomy

- Adhesiolysis

- Coagulation of blebs and bullae

Pulmonology:

Endoscopic pulmonary applications

Tracheal bronchial lesions

Benign an malignant pulmonary obstruction

Otolaryngology ENT:

Removal of benign lesions from the ear, nose and throat

Excision of carcinoma of the larynx

Incision and excision of carcinoma in situ

Neck dissection

Laryngeal papillomectomy

Removal of vocal cord/fold nodules, polyps and cyst

Dental Application:

- Frenectomy

- Frenotomy

- Biopsy

- Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening

Pulmonary Surgery:

- Endoscopic pulmonary applications

- Tracheal bronchial lesions

- Benign and malignant pulmonary or stricture

Cardiac Surgery:

- Coagulation and hemostasis of cardiac tissue

Dermatology/Aesthetics:

- Photocoagulation of vascular & dermatological lesions of the face and extremities

- Photocoagulation of telangiectasia, veinulectasia of the legs and face

- Treatment of reticular veins and branch varicosities

- Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas

- Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.

- Dermatological surgery: Condyloma acuminate, warts, small non malignant skon tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment.

- Seborrheic keratosis

- Mixoid cyst

- Papillary varix

- Acne treatment

- Hair removal of unwanted hair from skin type I-V

Plastic Surgery:

- Cut, coagulation & vaporization

- Resurfacing non

- Blepharoplasty

Vascular Surgery:

- Endoluminal or endovenous laser surgery for saphenous incompetent veins

LASER 940nm:

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology.

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficialvein reflux.

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are intended for use in the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or lateral lobes ranging in total volume from 28-85 cc.

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:Excisional and incisional biopsies Exposure of unerupted teeth; Fibroma removal; Frenectomy; Frenotomy; Gingival troughing for crown impressions; Gingivectomy; Gingivoplasty; Gingival incision and excision; Haemostasis and coagulation; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomny; Pulpotomy as an adjunct to root canal therapy; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa; Vestibuloplasty

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for Laser Periodontal procedures, including: Laser soft tissue curettage; Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket; Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)

LASER 980nm:

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are 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 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 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 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 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 (BPH)

Gynecology

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

- Endometrial ablation

- Excision or vaporization of condylomata acuminata

- 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

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are 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.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

LASER 1064nm

DERMATOLOGY/ PLASTIC SURGERY

Photocoagulation:

Colored Vascular Lesions of Skin (only if Argon Laser is unsuccessful)

DISCECTOMY

Percutaneous Lumbar Discectomy

GASTROINTESTINAL

Tissue Ablation:

Benign and Malignant Neoplasm

Polyps

Colitis

Ulcers

Aniodysplasia

Hemorrhoids

Hemostasis:

Varices

Esophangitis

Esophageal Ulcer

Mallory-Weiss Tear

Gastric Ulcers

Duodenal Ulcers

Non-bleeding Ulcers

Gastric Erosions

GENERAL SURGERY

Soft Tissue:

Skin Incision

Tissue Dissection

Excision (external tumors and lesions)

Resection of Internal Organs (complete or partial)

Tumors and Lesions

Tissue Ablation

Vessel Coagulation

GENITOURINARY SURGERY

Ablation and Hemostasis:

Superficial Urinary Bladder Tumors

Invasive Bladder Carcinoma

Urethral Strictures

Lesions of the External Genitalia

GYNECOLOGICAL TISSUE ABLATION

Endometrial Ablation (menorrhagia)

Soft Tissue Excisional Conization

Submuccous Fibroids

Polyps

Septa

NEUROSURGERY

Hemostasis

ORTHOPEDIC SURGERY

Soft Tissue (incision and excision):

Knee

Shoulder

OTORHINOLARYNGOLOGY SURGERY

Soft Tissue:

Skin Incision

Tissue Dissection

Excision (external tumors and lesions)

Resection of Internal Organs (complete or partial)

Tumors and Lesions

Tissue Ablation

Vessel Coagulation

PROSTATECTOMY

Soft Tissue Coagulation:

Benign Prostatic Hyperplasia (BPH Prostatectomy)

PULMONARY SURGERY

Palliative Treatment:

Benign and Malignant Pulmonary Airway Obstructions

LASER 1320 nm

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. For treatment of back acne and atrophic acne scars. For treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities.

LASER 1470nm:

The Quanta System Polysurge Diode Laser Family (and their delivery accessories used to deliver optical energy) are indicated for delivery of laser light to soft tissue in non-contact mode during general surgery procedures. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

LASER 1950nm:

Urology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Urethral strictures

- Bladder neck incisions

- Ablation and resection of bladder tumors, urethral tumors and ureteral tumors

Ablation of Benign Prostatic hypertrophy (BPH)

Transurethral incision of the prostate (TUIP)

Laser Resection of the Prostate (HoLRP)

- Laser Enucleation of the Prostate (HoLEP)

Laser Ablation of the Prostate (HoLAP)

Condylomas

- Lesions of the external genitalia

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

- Appendectomy

- Polyps

- Biopsy

- Gall Bladder calculi

- Biliary/bile duct calculi

- Ulcers

- Gastric ulcers

- Duodenal ulcers

- Non-bleeding ulcers

- Pancreatitis

- Hemorrhoids

- Cholecystectomy

- Benign and malignant neoplasm

- Angiodysplasia

- Colorectal cancer

- Telangiectasias

- Telangiectasias of the Osler-Weber-Renu disease

- Vascular malformation

Gastritis

Esophagitis

Esophageal ulcers

Varices

Colitis

Mallory-Weiss tear

Gastric erosions

Thoracic/Pulmonary Surgery

Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including

Laryngeal lesions

Airway obstruction including carcinoma

Polyps and granulomas

Palliation of obstructing carcinomas of the tracheobronchial tree

Gynecology

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including

Intra-uterine treatment of submucous fibroids, benign

endometrial polyps and uterine septum by incision, excision,

ablation and or vessel coagulation

Soft tissue excision procedures such as excisional conization of

the cervix

Ear, Nose and Throat (Otolaryngology)

Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

- Endonasal/sinus surgery

- Partial turbinectomy

- Polypectomy

- Dacryocystorhinostomy

- Frontal sinusotomy

- Ethmoidectomy

- Maxillary antrostomy

- Functional endoscopic sinus surgery

- Lesions or tumors of the oral, nasal, glossal, pharyngeal and

- laryngeal

- Tonsillectomy

- Adenoidectomy

Dermatology/Plastic Surgery

Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue in therapeutic plastic, dermatologic and aesthetic procedures including:

Basal Cell carcinomas

Lesions of the skin and subcutaneous tissue

Skin tags

Plantar warts

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue)

Ablation of soft and cartilaginous tissue in minimally invasive spinal surgery including:

Percutaneous laser disc decompression/discectomy (PLDD)

Foraminoplasty

Ablation and coagulation of soft vascular and non vascular tissue

General Surgery

Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

- Cholecystecomy

- Lysis of adhesions

Appendectomy

Biopsy

Skin incision

Tissue dissection

- Excision of external tumors and lesions

Complete or partial resection of internal organs, tumors and lesions

- Mastectomy

- Hepatectomy

- Pancreatectomy

- Splenectomy

- Thyroidectomy

- Parathyroidectomy

- Herniorrhaphy

- Tonsillectomy

- Lymphadenectomy

- Partial nephrectomy

- Pilonidal Cystectomy

- Resection of hpoma

- Debridement of decubitus ulcers

- Hemorrhoids

- Debridement of statis ulcers

- Biopsy