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

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 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 systemn), pulmonary surgery,

cardiothoracic surgery, dental appilications, and endovenous occlusion of the

saphenous veins in patients with superficial vein reflux. The Multiwavelength laser

is further indicated for laser assisted lipolysis.

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

Artbroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation of joint

tissues during artliroscopic surgery. Examples includey~/( i

Menisectomy (6W'~ / UAC X '--

Synovectomy (Division Sigrf-O$f

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and Restorative Devices

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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 waits

Excision of plantar warts

Excision of keloids

Liver resection

Excision of cutaneous lesions

Hemorrhoidectomy

Appendectomy

Debridement ofdecubitus 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 patholo~ 4 ~,

Pildnidal cystectomy (Division Sign-Off

Herniorapphy Division of Surgical, Orthopedic,

Adhesiolysis and Restorative Devices

Parathyroidectomy

Laparoscopic cholecystectomy

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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 (BPI-). Note: powers from

15 1W to 200W should only be applied in the vaporizatioin 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 ablati n of soft tissue

in the pulmonary system. $%n ,yaj/& f

Examples include: (Division Signot

Tracheobronchial malignancy or stricture Division of Surgical, Orthopedic,

Benign and malignant pulmonary obstruction and Restorative Devices

Endoscopic pulmonary applications.

Dental Applications 510(k) Number_1_2_0_-_- ___

Indicated for the following applications on mntradral and extraoral soft tissue

(including marginal and interdental gingival and epithelial lining of free gingival):

frenectomy, frenotomy, biopsy, opercfilectomy, 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 banal 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 Hyperplasia (BPH).