K Number

Device Name

QUANTA DIODE LASER SYSTEM

Manufacturer

QUANTA SYSTEM, S.P.A.

Date Cleared

2010-07-22

(143 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

The Quanta System QUANTA Diode Laser Family, including the QUANTA532, QUANTA808, QUANTA940, QUANTA980, QUANTA1064, QUANTA1320, QUANTA1470, and QUANTA1950 (and all their double wavelength combination 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. The QUANTA980 and QUANTA1470 Diode Laser are further indicated for laser assisted lipolysis.

Device Description

The QUANTA Diode Laser Family is designed with 4 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics, which controls the power electronics, the user interface and the laser source temperature via a thermostat board: and (4) the laser system with an opto-mechanical block composed of the laser source, the Peltier cooling system with dissipater and fans, the fiber launching system, the red diode aiming beam, and the power calibration system. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the QUANTA 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 and laser assisted lipolysis.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K072034, K083613, K091534, K053604, K090164

Reference Devices

K072034, K083613, K091534, K053604, K090164

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser system with standard hardware components and control electronics. There is no mention of AI, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML integration in medical devices.

Therapeutic

Yes

The device is indicated for various surgical applications requiring the vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue, which directly relate to the treatment of medical conditions.

Diagnostic

The device is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including an external structure, power electronics, display with control electronics, and a laser system with an opto-mechanical block. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is used for surgical applications requiring the vaporization, incision, excision, ablation, cutting, hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment. These are all procedures performed directly on a living patient.
Device Description: The description details a laser system designed to deliver optical energy for surgical procedures. It mentions components like a laser source, cooling system, fiber launching system, and accessories for dental, dermatological, surgical, endovascular, and lipolysis applications. None of these components or functions are related to testing samples in vitro (outside of the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.

In summary, the device is a surgical laser system used for treating patients directly, not for performing diagnostic tests on samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Quanta System QUANTA Diode Laser Family, including the QUANTA532, QUANTA808, QUANTA940, QUANTA980, QUANTA1064, QUANTA1320, QUANTA1470, and QUANTA1950 (and all their double wavelength combination and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, 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. The QUANTA980 and QUANTA1470 Diode Laser are further indicated for laser assisted lipolysis.

LASER 808nm and 980nm
Urology:

Lesions of external genitalia
Circumcision
Condvloma .
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)
Condvloma
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
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 Telangiectasias, including 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
Blepharoplastv

Vascular Surgery:

Endoluminal or endovenous laser surgery for saphenous incompetent veins

LASER 940nm:
The Quanta System QUANTA 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 QUANTA 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/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 QUANTA 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 QUANTA 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 QUANTA 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 QUANTA 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 QUANTA980 Diode 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 larvnx
Larvngeal 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 ﺖ
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 ﺘﻪ
Adhesiolysis
Parathvroidectomy -
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 gynecologica tissue. Examples include:

Endometrial ablation
Excision or vaporization of condylomata acuminatalivision of Surgical, Orthopedic, -
Enolon of Yaporization of contal lonkala acoulariata
Vaporization of cervical intraepithelial neoplasia and Restorative Devices -
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 QUANTA 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 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 Obstructible) Number .

LASER 1320 nm
The Quanta System QUANTA 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 Diode Laser System is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The QUANTA Diode Laser System is generally indicated for use in endovenous occlusion of the greater saphenous vein. The QUANTA1470 Diode Laser System is further indicated for laser assisted lipolysis.

The device is specifically indicated for use as follows:

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
D uodenal 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)
Foraminoplastv
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 lipoma
Debridement of decubitus ulcers
Hemorrhoids
Debridement of statis ulcers
Biopsy

LASER 532nm:
Ophthalmology:

Retinal Photocoagulation .
Pan Retinal Photocoagulation .
. Endophotocoagulation
Macular Treatments .
Laser Trabeculoplasty .

Otolaryngology:

Stapedectomy
Stapedotomy ●
Myringotomy .
Lysis of adhesions .
Control of bleeding .
Removal of acoustic neuromas .
Soft tissue adhesion in micro/macro otologic procedures. .

Dermatology:

Vascular lesion .
Pigmented lesion .

Product codes

GEX

Device Description

The QUANTA Diode Laser System includes 36 models (8 single wavelength and 28 double wavelength) :
Models, Wavelength, Laser Power
QUANTA532, 532nm, 8W
QUANTA808, 808nm, 30W
QUANTA940, 940nm, 30W
QUANTA980, 980nm, 30W
QUANTA1064, 1064nm, 30W
QUANTA1320, 1320nm, 10W
QUANTA1470, 1470nm, 15W
QUANTA1950, 1950nm, 5W

Model QUANTA 532 is indicated for Ophthalmology, Otolaryngology and Dermatology
QUANTA808 is indicated for Urology Model (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 QUANTA940 is indicated for Urology Plastic Surgery, General Surgery, (BPH), Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology, Endovascular Surgery and Dental Procedures.
Model QUANTA980 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. It is also indicated for Laser Assisted Lipolysis
Model QUANTA1064 is indicated for use in Dermatology/ Plastic Surgery, Discectomy, Gastrointestinal Surgery, General Surgery, Genitourinary Surgery, Gynecological Tissue Neurosurgery, Ablation, Orthopedic Surgery, Otorhinolaringology Surgery, Prostatectomy. Pulmonary Surgery.
Model QUANTA1320 is indicated for use in Dermatology and endovascular surgery.
Model QUANTA1470 is indicated for use in endovascular surgery and for laser assisted lipolysis.
Model QUANTA1950 is indicated for use in Urology, Gastroenterology, Thoracic/Pulmonary Surgery, Gynecology, Ear, Nose and Throat (Otolaryngology), Dermatology/Plastic Surgery, Arthroscopy, General Surgery

The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications and laser assisted lipolysis.

NOTE: In all double wavelength models it's possible to use only one at a time. It's not possible to use them simultaneously or sequentially. In double models the different wavelengths are delivered throught two different optical fibers and hanpieces. The software allows the operator to choose and use a single wavelength at a time. To switch from one wavelength to another the laser device must be always switched off and switched on. In this way it's impossible to use two wavelengths simultaneously or sequentially.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue, external genitalia, bladder, rectum, anus, breast, appendix, bowel, liver, organs, thyroid, meningiomas, cervix, myoma, endometrium, ovary, eye (dacryocystorhinostomy, DCR, tumors, blepharoplasty), joints (chondromalacia, synovectomy, menisci), colon, esophagus, polyps, thorax, pulmonary system, ear, nose, throat, larynx, vocal cords, dental (frenum, gingiva, teeth, oral mucosa), heart, skin, face, extremities, reticular veins, branch varicosities, saphenous vein, prostate, urethra, kidney, spinal disc, shoulder.

Indicated Patient Age Range

Intended User / Care Setting

Medical specialist

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

None

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Quanta System Diode Medical Laser Family (K072034); Quanta System Polysurge Diode Laser Family (K083613) - Lightmed LightLas 532 (K091534) - Quantel IDAS (K053604) - Biolitec Ceralas Multiwavelength 980/1470nm Diode Laser System (K090164)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

Quanta System S.p.a. Via IV Novembre 116, SOLBIATE OLONA (VA)	510(K) PREMARKET NOTIFICATION		FDA F D 0.02.C
	Product QUANTA DIODE LASER FAMILY	Revision 13/03/2010	Page 44 of 167
Title:	510(k) SUMMARY	Quanta System QUANTA Diode Laser Family	K100558
Submitter:	Quanta System SpA via IV Novembre,116 21058 Solbiate Olona VA / Italy		JUL 2 2 2010
Contact:	Dr. Isabella Carrer Medical Division Manager
Date Prepared:	October 29, 2009
Device Trade Name:	Quanta System QUANTA Diode Laser Family
Common Name:	Laser surgical instrument for use in general surgery and dermatology
Classification Name:	Instrument, surgical, powered, laser
Predicate Devices:	- Quanta System Diode Medical Laser Family (K072034); - Quanta System Polysurge Diode Laser Family (K083613) - Lightmed LightLas 532 (K091534) - Quantel IDAS (K053604) - Biolitec Ceralas Multiwavelength 980/1470nm Diode Laser System (K090164)
Intended Use / Indications for Use:	The Quanta System QUANTA Diode Laser Family, including the QUANTA532, QUANTA808, QUANTA940, QUANTA980, QUANTA1064, QUANTA1320, QUANTA1470, and QUANTA1950 (and all their double wavelength combination 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. The QUANTA980 and QUANTA1470 Diode Laser are further indicated for laser assisted lipolysis.

Revision

13/03/2010

LASER 808nm and 980nm

Urology:

Product

QUANTA DIODE

LASER FAMILY

. 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 and (open lapararscopic)
Condyloma
Breast biopsy

Neurosurgery:

Percutaneous Disc Decompression → (PLDD)
Discectomy -
Hemostasis in conjunction with meningiomas

Gynecology:

Cervical conization
Myomectomy
Endometrial ablation -
Ovarian cystectomy -
Appendectomy

SOLBIATE OLONA (VA)

Product QUANTA DIODE LASER FAMILY

Ophthalmology:

Dacryocystorhinostomy transcanalicular
Revision

13/03/2010

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 ﮯ

SOLBIATE OLONA (VA)

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

Pulmonary Surgery:

Endoscopic pulmonary applications
Revision

13/03/2010

Tracheal bronchial lesions
Benign and malignant pulmonary or stricture

Cardiac Surgery:

Coagulation and hemostasis of cardiac tissue

Dermatology/Aesthetics:

Photocoagulation of vascular & ー 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 lymphangiomatosis and 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

Cut, coagulation & vaporization -
Resurfacing non -
Blepharoplasty

Vascular Surgery:

Endoluminal endovenous or laser saphenous incompetent surgery for veins

LASER 940nm:

The Quanta System QUANTA 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 QUANTA 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 QUANTA 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

Quanta System S.p.a.

Via IV Novembre 116, SOLBIATE OLONA (VA)

Product QUANTA DIODE LASER FAMILY

marginal and inter-dental gingival and epithelial lining free gingival and the following specific of 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 QUANTA Diode Laser Family (and their delivery accessories used to deliver optical energy) Laser Periodontal procedures, are indicated for 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 QUANTA 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 QUANTA980 Diode 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

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.

Quanta System S.p.a.
Via IV Novembre 116,
SOLBIATE OLONA (VA)

Examples include:

-Matrixectomy
Excision of neuromas -
Excision of periungual and subungual warts

Revision

13/03/2010

Excision of plantar warts -
Excision of keloids -
Liver resection -
Excision of cutaneous lesions -
Hemorrhoidectomy -
Appendectomy -
Debridement of decubitus ulcers -
Hepatobiliary tumors ー
Mastectomy -
Dermabrasion -
Vaporization and hemostasis of capillary hemangioma
-Excision, vaporization and hemostasis of abdominal tumors
Excision, vaporization and hemostasis of rectal pathology
Pilonidal cystectomy t
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 -

Revision

13/03/2010

Lesions of external genitalia -
Vaporization of the prostate to treat benign ー 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

Product QUANTA DIODE LASER FAMILY

Revision 13/03/2010

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 therapy and light activation of bleaching canal 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.

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

Revision

13/03/2010

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 QUANTA 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 Diode Laser System is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The QUANTA Diode Laser System is generally indicated for use in endovenous occlusion of the greater saphenous vein. The QUANTA1470 Diode Laser is further indicated for laser assisted lipolysis.

Revision

13/03/2010

The device is specifically indicated for use as follows:

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.

LASER 1950nm:

Urology

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

Urethral strictures -
. Bladder neck incisions
ﺖ 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

Product QUANTA DIODE LASER FAMILY

and hemostasis) including:

Appendectomy -
-Polyps
Biopsv -
Gall Bladder calculi -
Biliary/bile duct calculi -
Ulcers .
Gastric ulcers -
D uodenal ulcers -
Non-bleeding ulcers -
Pancreatitis -
Hemorrhoids -
Cholecystectomy -
Benign and malignant neoplasm -

Revision

13/03/2010

Angiodysplasia -
Colorectal cancer -
-Telangiectasias
Telangiectasias of the Osler-Weber--Renu disease
Vascular malformation -
Gastritis -
Esophagitis
Esophageal ulcers ﺖ
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

Revision

13/03/2010

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 ー
Frontal sinusotomy -
Ethmoidectomy -
Maxillary antrostomy -
Functional endoscopic sinus surgery -
Lesions or tumors of the oral, nasal, glossal, pharyngeal and
laryngeal -
Tonsillectomy
Adenoidectomy ﮯ

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)
Revision
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 lipoma
Debridement of decubitus ulcers
Hemorrhoids
Debridement of statis ulcers
Biopsy

LASER 532nm:

Ophthalmology:

. Retinal Photocoagulation
Pan Retinal Photocoagulation ●
. Endophotocoagulation
Macular Treatments .

Laser Trabeculoplasty .

Otolaryngology:

Stapedectomy .
Stapedotomy �
Myringotomy ●
Lysis of adhesions �
Control of bleeding ●
Removal of acoustic neuromas
Soft tissue adhesion in micro/macro otologic procedures.

Dermatology:

Technological Characteristics:

. Vascular lesion
Pigmented lesion ●

The QUANTA Diode Laser System includes 36 models (8 single wavelength and 28 double wavelength) :

Models	Wavelength	Laser Power
QUANTA532	532nm	8W
QUANTA808	808nm	30W
QUANTA940	940nm	30W
QUANTA980	980nm	30W
QUANTA1064	1064nm	30W
QUANTA1320	1320nm	10W
QUANTA1470	1470nm	15W
QUANTA1950	1950nm	5W

Model QUANTA 532 is indicated for Ophthalmology, Otolaryngology and Dermatology
QUANTA808 is indicated for Urology Model (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.

Quanta System S.p.a.	510(K) PREMARKET NOTIFICATION
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product	Revision	Page 61 of 167
	QUANTA DIODE
LASER FAMILY	13/03/2010

Model QUANTA940 is indicated for Urology Plastic Surgery, General Surgery, (BPH), Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT, Radiology, Endovascular Surgery and Dental Procedures.
Model QUANTA980 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. It is also indicated for Laser Assisted Lipolysis
Model QUANTA1064 is indicated for use in Dermatology/ Plastic Surgery, Discectomy, Gastrointestinal Surgery, General Surgery, Genitourinary Surgery, Gynecological Tissue Neurosurgery, Ablation, Orthopedic Surgery, Otorhinolaringology Surgery, Prostatectomy. Pulmonary Surgery.
Model QUANTA1320 is indicated for use in Dermatology and endovascular surgery.
Model QUANTA1470 is indicated for use in endovascular surgery and for laser assisted lipolysis.
Model QUANTA1950 is indicated for use in Urology, Gastroenterology, Thoracic/Pulmonary Surgery, Gynecology, Ear, Nose and Throat (Otolaryngology), Dermatology/Plastic Surgery, Arthroscopy, General Surgery

| Quanta System S.p.a.
Via IV Novembre 116,

SOLBIATE OLONA (VA)	510(K) PREMARKET NOTIFICATION		FDA F D 0.02.C
	Product
QUANTA DIODE
LASER FAMILY	Revision
13/03/2010	Page 62 of 167

system. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the QUANTA 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 and laser assisted lipolysis.

Performance Data None

Substantial Equivalence:

The Quanta System QUANTA Diode Laser Family is as safe and effective as the predicate devices. The QUANTA 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 QUANTA Diode Laser Family and its predicate devices raise no new issues of safety or effectiveness. Thus, the QUANTA Diode Laser Family is substantially equivalent.

Image /page/19/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

· JUL 2.2 2010

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

Re: K100558

Trade/Device Name: QUANTA 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: Class II Product Code: GEX

Dated: July 20, 2010 Received: July 21, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Page 2 - Mr. Mark Job

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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 1 of 14

Indications for Use Statement

510(k) Number (if known):

Device Name: QUANTA Diode Laser Family

Indications for Use:

The Quanta System QUANTA Diode Laser Family, including the QUANTA532, QUANTA808, QUANTA940, QUANTA980, QUANTA1064, QUANTA1320, QUANTA1470, and QUANTA1950 (and all their double wavelength combination and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, 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. The QUANTA980 and QUANTA1470 Diode Laser are further indicated for laser assisted lipolysis.

LASER 808nm and 980nm

Urology:

Lesions of external genitalia
Circumcision
Condvloma .
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)
Condvloma
Breast biopsy

Mark N. Milluson

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Divisionative Devices

510(k) Number K100558

・・・・・

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 2 of 14

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

510(k) Number K1005

(Division Sign-Sign-Sical, Orthopedic, and Restorative Devices

Mark
(Division Sign-Off)

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 3 of 14

Neck dissection
Laryngeal papillomectomy
Removal of vocal cord/fold nodules, polyps and cyst

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 Telangiectasias, including 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:

Sign-Off)
of Surgical, Orth
rative Devices

Cut, coagulation & vaporization
Resurfacing non
Blepharoplastv

Vascular Surgery:

Endoluminal or endovenous laser surgery for saphenous incompetent veins

LASER 940nm:

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 4 of 14

The Quanta System QUANTA 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; 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

Marke N. Maffett
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K100538

510(k) Number .

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA FD 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 5 of 14

LASER 980nm:

The Quanta System QUANTA 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 QUANTA980 Diode 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 larvnx
Larvngeal 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

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 6 of 14

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 ﺖ
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 ﺘﻪ
Adhesiolysis
Parathvroidectomy -
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)

Image /page/26/Figure/38 description: The image shows the text "Written by: MED". The text is in a bold, sans-serif font. The words "Written by:" are on the left, and the word "MED" is on the right. The text is likely part of a document or report, indicating the author of the work.

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 7 of 14

Gynecology

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

Endometrial ablation ।
(Division Sign-Off)
Excision or vaporization of condylomata acuminatalivision of Surgical, Orthopedic, -
Enolon of Yaporization of contal lonkala acoulariata
Vaporization of cervical intraepithelial neoplasia and Restorative Devices -
Cervical conization "
Menorrhagia

510(k) Number K100558

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 QUANTA 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 in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

:....:

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 8 of 14

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

Mark A. Milkerian

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100558

... ..

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 9 of 14

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) .
Mark H. Wilkerson

(Division Sign-Oft) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Surfative Devices

510(k) Number -

K100538

Quanta System S.p.a.

Via IV Novembre 116. SOLBIATE OLONA (VA) INDICATIONS FOR USE STATMENT FDA F D 14.01.A Product QUANTA DIODE LASER FAMILY

Revision	07/06/2010
Page 10 of 14	A M

K100558

PULMONARY SURGERY

Palliative Treatment:

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Benign and Malignant Pulmonary Airway Obstructible) Number .

LASER 1320 nm

LASER 1470nm:

The device is specifically indicated for use as follows:

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.

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)

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 11 of 14

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
D uodenal 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

Mark N. Mulkein
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100538

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT		FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 12 of 14

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

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)
Foraminoplastv
Ablation and coagulation of soft vascular and non vascular tissue

K100358
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number .

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT	FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 13 of 14

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 lipoma
Debridement of decubitus ulcers
Hemorrhoids
Debridement of statis ulcers
Biopsy

Muk M. Millers
(Division Sign-Off)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

K100558

Quanta System S.p.a.	INDICATIONS FOR USE STATMENT		FDA F D 14.01.A
Via IV Novembre 116,
SOLBIATE OLONA (VA)	Product
QUANTA DIODE
LASER FAMILY	Revision
07/06/2010	Page 14 of 14

LASER 532nm:

Ophthalmology:

Retinal Photocoagulation .
Pan Retinal Photocoagulation .
. Endophotocoagulation
Macular Treatments .
Laser Trabeculoplasty .

Otolaryngology:

Stapedectomy
Stapedotomy ●
Myringotomy .
Lysis of adhesions .
Control of bleeding .
Removal of acoustic neuromas .
Soft tissue adhesion in micro/macro otologic procedures. .

Dermatology:

Vascular lesion .
Pigmented lesion .

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)

Checked by:

Mark M. Mulkerson

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Surges
and Restorative Devices

K10058

510(k) Number __