The Quanta System Polysurge Diode Laser Family, including the Polysurge808, Polysurge940, Polysurge980, Polysurge1064, Polysurge1320, Polysurge1470 and Polysurge1950 (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, Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

Device Description

The Polysurge Diode Laser System includes seven models: Polysurge808, Polysurge940, Polysurge980, Polysurge1064, Polysurge1320, Polysurge1470 and Polysurge1950 with different wavelengths and laser power. The Polysurge Diode Laser Family is designed with 5 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics; (4) the laser system with an opto-mechanical block and (5) the cooling system. In addition to the five subsystems, the Polysurge Diode Laser Family incorporates several safety features, including a remote interlock, an emergency red push button and a key switch. The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications.

AI/ML Overview

This 510(k) summary for the Quanta System Polysurge Diode Laser Family does not contain specific acceptance criteria or details of a study proving the device meets acceptance criteria in the manner one might expect for a diagnostic or AI-driven device.

Instead, this document focuses on establishing substantial equivalence to predicate devices. For medical devices that are not significantly different from devices already legally marketed (predicate devices), the FDA’s 510(k) pathway allows market clearance withoutrequiring new clinical trials to demonstrate safety and effectiveness from scratch.

This means the "study that proves the device meets the acceptance criteria" is implicitly the demonstration that the new device is as safe and effective as the predicate devices, which were themselves proven safe and effective through prior regulatory processes. The acceptance criteria are therefore aligned with the performance and safety characteristics of those predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit - Derived from Predicate Devices): The Quanta System Polysurge Diode Laser Family must demonstrate clinical performance (vaporization, incision, excision, ablation, cutting, hemostasis, coagulation of soft tissue, etc.) across various medical specialties and for specific applications, comparable to the predicate devices. The safety profile must also be comparable.

Reported Device Performance:
The document does not provide specific quantitative performance metrics for the Quanta System Polysurge Diode Laser Family. Instead, it relies on the principle of substantial equivalence, stating:

"The Quanta System Polysurge Diode Laser Family is as safe and effective as the predicate devices. The Polysurge Diode Laser Family has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Polysurge Diode Laser Family and its predicate devices raise no new issues of safety or effectiveness. Thus, the Polysurge Diode Laser Family is substantially equivalent."

The performance is "reported" by defining its intended uses and indications for use across multiple wavelengths and medical specialties, implying that it performs these functions equivalently to the predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance
The device must be safe and effective for its intended uses and indications, demonstrating comparable clinical outcomes (e.g., efficacy in vaporization, incision, excision, ablation, cutting, hemostasis, coagulation of soft tissue, and specific applications across various medical specialties) as the predicate devices. This includes ensuring the stated wavelengths and power outputs achieve the clinical effects without new safety concerns.	The document asserts: "The Quanta System Polysurge Diode Laser Family is as safe and effective as the predicate devices. The Polysurge Diode Laser Family has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Polysurge Diode Laser Family and its predicate devices raise no new issues of safety or effectiveness. Thus, the Polysurge Diode Laser Family is substantially equivalent." The device's performance is therefore implicitly deemed satisfactory based on the established safety and efficacy of the predicate devices. The vast list of indications for use (spanning multiple pages) serves as the "reported performance" by demonstrating the broad range of applications for which equivalence is claimed.
Must meet the clinical performance standards set by the predicate devices: - Quanta System Diode Medical Laser Family (K072034) - INTERmedic Diode Laser Family (K053540) - Dornier Medilase D Family Laser (K070536) - Biolitec 150W Ceralas D 980nm Diode Laser (K072106) - Trimedyne Optilase PL100 Nd:YAG Laser (K932883) - CoolTouch LC215 Nd:YAG Laser (K072424) - Biolitec 15W Ceralas D 1470nm Diode (K073063) - Biolitec 50W Ceralas D 1950nm Diode (K072682)	The device's performance is argued to be "substantially equivalent" to these specific predicate devices. The document highlights that the new device shares "the same intended uses and similar indications, technological characteristics, and principles of operation."
Ensure that any "minor technological differences" (e.g., variations in specific wavelengths or power outputs within the family) do not introduce any new safety or effectiveness concerns compared to the predicate devices.	The submission explicitly states: "The minor technological differences between the Polysurge Diode Laser Family and its predicate devices raise no new issues of safety or effectiveness." This implies that the sponsor presented evidence (e.g., bench testing, engineering analysis) to FDA to demonstrate that these differences do not negatively impact safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study or a test set with a specific sample size in the context of proving the device meets acceptance criteria for a new clinical performance claim. The evidence provided is primarily based on a comparison to predicate devices, focusing on technological characteristics and intended uses.

Therefore, details such as data provenance (country of origin, retrospective/prospective) are not provided because a dedicated clinical study for this 510(k) submission is not presented.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. Since no new clinical study (test set) is described, there's no mention of experts establishing a ground truth for a test set. The "ground truth" for the device's safety and effectiveness is implicitly established by the regulatory clearance of the predicate devices.

4. Adjudication Method

Not applicable, as no new clinical study (test set) is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study would typically be performed for diagnostic imaging devices to assess the impact of AI on human readers. The Quanta System Polysurge Diode Laser Family is a surgical laser, and its clearance is based on substantial equivalence, not an MRMC study.

6. Standalone Performance

The concept of "standalone performance" for a surgical laser would refer to its inherent ability to perform the stated functions (vaporization, cutting, etc.) as an algorithm-only device would for AI. While the laser itself is a standalone device in operation, the document doesn't provide specific performance metrics from standalone testing in the way an AI algorithm's standalone performance might be reported (e.g., sensitivity, specificity). Its "standalone performance" is implicitly that it functions as described and comparable to predicate devices.

7. Type of Ground Truth Used

The "ground truth" for the safety and effectiveness of the Quanta System Polysurge Diode Laser Family is the prior regulatory clearance and established safety/effectiveness of the predicate devices. This is explicitly stated in the substantial equivalence claim. There is no mention of pathology, outcomes data, or expert consensus being used to establish a new ground truth for this submission, as it leverages the existing regulatory history of similar devices.

8. Sample Size for the Training Set

Not applicable. This device is a surgical laser, not an AI/machine learning model, so there is no training set in the context of data used to train an algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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K083613

510(k) SUMMARY Quanta System Polysurge Diode Laser Family

Title:

ner อน

	DEC 23 2008
Submitter:	Quanta System SpAvia IV Novembre,11621058 SolbiateOlona VA / Italy
Contact:	Dr. Isabella CarrerMedical Division Manager
Date Prepared:	June 16, 2008
Device Trade Name:	Quanta System Polysurge Diode Laser Family
Common Name:	Laser surgical instrument for use in general surgery anddermatology
Classification Name:	Instrument, surgical, powered, laser
Predicate Devices:	- Quanta System Diode Medical Laser Family (K072034);- INTERmedic Diode Laser Family (K053540);- Dornier Medilase D Family Laser (K070536);- Biolitec 150W Ceralas D 980nm Diode Laser (K072106);- Trimedyne Optilase PL100 Nd:YAG Laser (K932883);- CoolTouch LC215 Nd:YAG Laser (K072424);- Biolitec 15W Ceralas D 1470nm Diode (K073063).- Biolitec 50W Ceralas D 1950nm Diode (K072682).
Intended Use /Indications for Use:	The Quanta System Polysurge Diode Laser Family, including the Polysurge808, Polysurge940,Polysurge980, Polysurge1064, Polysurge1320, Polysurge1470 and Polysurge1950 (and their deliveryaccessories used to deliver optical energy) are indicatedfor use in surgical applications requiring thevaporization, incision, excision, ablation, cutting andhemostasis, or coagulation of soft tissue in conjunctionwith endoscopic equipment for medical specialistincluding: Urology (BPH), Genitourinary (Urology)

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Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgerv. Ophthalmology, Orthopedics. Podiatry, Arthroscopy, Spinal Surgery, Gynecology. Pulmonary Surgery, Neurosurgery, 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 -
ﺘ Endometrial ablation
Ovarian cystectomy -
Appendectomy

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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 ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
-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

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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 . હિદ 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 r
Acne treatment -
Hair removal of unwanted hair from skin type I-V

Plastic Surgery:

Cut, coagulation & vaporization
Resurfacing non
Blepharoplasty

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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) indicated for incision, excision, vaporization, are ablation and coagulation of oral soft tissue including marginal and inter-dental gingival and epithelial lining free gingival and the following of specific indications:Excional and incisional biopsies Exposure of unerupted teeth; Fibroma removal; Frenectomy; Frenotomy; Gingival troughing for crown impressions;

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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, plastic surgery, podiatry, urology, dermatology, 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:

Nose Ear. 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
ﯩﺴ Excision and vaporization of vocal cord nodules and polyps
. Incision and excision of carcinoma in

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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 lesions, hemostasis, incision, skin 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 -
ﺳ Excision of keloids
Liver resection -
Excision of cutaneous lesions -

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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 -
ﺖ 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 -
ﺖ Excision or vaporization of condylomata acuminata
Vaporization of cervical intraepithelial

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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.

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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

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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 .

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· 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

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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) י
Condylomas .
Lesions of the external genitalia

Gastroenterology

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

Appendectomy -
ﺘ Polyps
-Biopsy
-Gall Bladder calculi
Biliary/bile duct calculi -
-Ulcers
Gastric ulcers .
D uodenal ulcers -
Non-bleeding ulcers -
Pancreatitis -
Hemorrhoids .
-Cholecystectomy
Benign and malignant neoplasm -
Angiodysplasia .
Colorectal cancer .
Telangiectasias ւ
Telangiectasias of the Osler-Weber--Renu disease
Vascular malformation -
Gastritis -
Esophagitis -
Esophageal ulcers -
Varices .
Colitis .
Mallory-Weiss tear -
Gastric erosions

Thoracic/Pulmonary Surgery

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

Laryngeal lesions .
ﺖ 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 ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

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

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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 -
Biopsv -
-Skin incision
. Tissue dissection
. Excision of external tumors and lesions
Complete or partial resection of internal organs, tumors and lesions
Mastectomy -
-Hepatectomy
Pancreatectomy -
Splenectomy -
Thyroidectomv -
-Parathyroidectomy
Herniorrhaphy -
-Tonsillectomy
Lymphadenectomy -
-Partial nephrectomy
Pilonidal Cystectomy .
-Resection of lipoma
Debridement of decubitus ulcers ー
Hemorrhoids -
Debridement of statis ulcers

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The Polysurge Diode Laser System includes seven models :

Models	Wavelength	Laser Power
Polysurge808	808nm	50, 90W
Polysurge940	940nm	50, 120W
Polysurge980	980nm	50, 100, 150W
Polysurge1064	1064nm	50, 100W
Polysurge1320	1320nm	10W
Polysurge1470	1470nm	15W
Polysurge1950	1950nm	50W

Model Polysurge808 is indicated for Urology (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy (PLDD), Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.
Model Polysurge940 is indicated for Urology (BPH). Plastic Surgery, General Surgery. Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology, Endovascular Surgery and Dental Procedures.
Model Polysurge980 is indicated for use in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology (BPH), gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein

{16}------------------------------------------------

Model Polysurge1064 is indicated for use in Endoscopic / Laparoscopic General Surgery, Gastroenterology, General Surgery, Gynecology, Head and Neck / Otorhinolaryngology (ENT), Neurosurgery, Orthopedics, Oculoplastics, Plastic Surgery, Pulmonary Surgery, Thoracic Surgery, Urology.
Model Polysurge1320 is indicated for use in Dermatology and endovascular surgery.
-Model Polysurge1470 is indicated for use in endovascular surgery.
-Model Polysurge1950 is indicated for use in Urology, Gastroenterology, Thoracic/Pulmonary Surgery, Gynecology, Ear, Nose and Throat (Otolaryngology), Dermatology/Plastic Surgery, Arthroscopy, General Surgery

The Polysurge Diode Laser Family is designed with 5 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics; (4) the laser system with an opto-mechanical block and (5) the cooling system. In addition to the five subsystems, the Polysurge Diode Laser Family incorporates several safety features, including a remote interlock, an emergency red push button and a key switch.

The external structure is composed of a polyurethane shell with a frontal panel containing the touch screen display, the optical fiber connection (SMA 905) and the calibration port. On this panel the key switch and the operation led are inserted too. On the rear panel the footswitch connectors, the remote interlock, the power switch, the RS232 interface connector are located . The emergency red push button is located on the upper part of the box.

The power electrical system is composed of a three power supply. The control electronic, based on a microcontroller, manage the power electronic, the current control, the thermalization of the laser source and control the user interface

The laser system is composed of an opto-mechanical block containing the laser source, the diode laser dissipation system (a Peltier's element and cooling system with distilled water), the fiber launching system, the red diode aiming beam, and the power calibration system.

The cooling system is composed of a water pump, a flow

{17}------------------------------------------------

Performance Data	switch, a heat exchanger, deionizing cartridge andwater filter.
SubstantialEquivalence:	The external accessories include separate optical fibersand hand pieces for dental, dermatological and surgicalapplications, or for endovascular applications.

None

The Quanta System Polysurge Diode Laser Family is as safe and effective as the predicate devices. The Polysurge Diode Laser Family has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Polysurge Diode Laser Family and its predicate devices raise no new issues of safety or effectiveness. Thus, the Polysurge Diode Laser Family is substantially equivalent.

{18}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/18/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing human services, knowledge, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2008

Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313

Rc: K083613

Trade/Device Name: Polysurge Diode Laser Family Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 5, 2008 Received: December 8, 2008

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

{19}------------------------------------------------

Page 2 - Mr. Mark Job

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Dcvice Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Mulhausen

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{20}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):_ K 08 3 6 13

Device Name: Polysurge Diode Laser Family

Indications for Use:

The Quanta System Polysurge Diode Laser Family, including the Polysurge808, Polysurge940, Polysurge980, Polysurge1064, Polysurge1320, Polysurge140, add Polysurge 1950 (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, inclision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitour nary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedies, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology, Endovascular coaculation, 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)

{21}------------------------------------------------

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 ﺍﻟ
Hemostasis of esophageal varices
Excision of polyps

Arthroscopy:

Chondromalacia ﺳ
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 ﮯ
Incision and excision of carcinoma in situ -
Neck dissection
Laryngeal papillomectomy -
Removal of vocal cord/fold nodules, polyps and cyst

{22}------------------------------------------------

Dental Application:

Frenectomy -
Frenotomy
-Biopsv
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:

{23}------------------------------------------------

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 hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, laparoscopes, and colonoscopies), in incision, 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 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

LASER 980nm:

ﮩ

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

{24}------------------------------------------------

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

{25}------------------------------------------------

Hemorrhoidectomy -
Appendectomy -
-Debridement of decubitus ulcers
Hepatobiliary tumors -
Mastectomy ﮯ
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

{26}------------------------------------------------

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, titssue 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 adiunct 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:

{27}------------------------------------------------

Benign and Malignant Neoplasm �
Polyps .
Colitis .
♥ Ulcers
Aniodysplasia ●
Hemorrhoids .

Hemostasis:

Varices �
. Esophangitis
Esophageal Ulcer .
. Mallory-Weiss Tear
Gastric Ulcers t
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 .

{28}------------------------------------------------

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

LASER 1470nm:

{29}------------------------------------------------

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 ー 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 ﮯ
Biopsv
Gall Bladder calculi
Biliary/bile duct calculi
Ulcers -
Gastric ulcers -
D uodenal ulcers .
Non-bleeding ulcers -
Pancreatitis ﺘ
Hemorrhoids -
-Cholecystectomy
Benign and malignant neoplasm -
Angiodysplasia ﻪ
Colorectal cancer
Telangiectasias
Telangiectasias of the Osler-Weber-Renu disease
Vascular malformation

{30}------------------------------------------------

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 ﮯ
Soft tissue excision procedures such as excisional conization of ﮯ
the cervix ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

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

{31}------------------------------------------------

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 ﻨﮯ

General Surgery

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

Cholecystecomy -
ﮯ Lysis of adhesions
Appendectomy -
Biopsv י
Skin incision -
-Tissue dissection
Excision of external tumors and lesions •
Complete or partial resection of internal organs, tumors and lesions -
ー Mastectomy
Hepatectomy -
Pancreatectomy -
-Splenectomy
Thyroidectomy ﮯ
ー Parathyroidectomy
Herniorrhaphy
Tonsillectomy t
-Lymphadenectomy
Partial nephrectomy .
-Pilonidal Cystectomy
Resection of lipoma -
-Debridement of decubitus ulcers
Hemorrhoids -
Debridement of statis ulcers ー

{32}------------------------------------------------

Biopsy

Prescription Use _X (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083613

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.