(57 days)
No
The document describes a diode laser system for surgical applications and does not mention any AI or ML components in the intended use, device description, or other sections.
Yes
The device is indicated for use in a wide range of surgical applications, including the ablation, vaporization, excision, incision, and coagulation of soft tissue across various medical specialties, as well as specific treatments like varicose veins and benign prostatic hyperplasia. These actions are clearly therapeutic interventions designed to treat disease or injury.
No
This device is a medical laser system designed for surgical applications, specifically for ablation, vaporization, excision, incision, and coagulation of soft tissue. Its function is to treat and modify tissue, not to diagnose conditions.
No
The device description clearly outlines hardware components including an external structure, power electronics, display with control electronics, and a laser system with opto-mechanical block, Peltier cooling system, fans, fiber launching system, aiming beam, and power calibration system. It also mentions external accessories like optical fibers and hand pieces. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. They perform tests outside of the living body.
- Device Intended Use: The intended use of the Quanta System Diode Medical Lasers Family is clearly described as being used for surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue within the human body.
- Anatomical Sites: The listed anatomical sites are all locations within the body where surgical procedures are performed.
- Device Description: The device description details a laser system with components for delivering laser energy for surgical purposes. There is no mention of analyzing biological specimens.
The device is a surgical laser system used for treating various conditions directly on or within the patient's body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
808 nm, 940 nm, 980nm Wavelengths
The Quanta System Diode Medical Lasers Family, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery
The Quanta System Diode Medical Lasers Family are indicated for use in the performance of specific surgical applications in gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics. ophthalmology, pulmonology, and thoracic surgery as follows:
Gastroenterology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy.
Neurosurgery (Medical 30, 6)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex.
General Surgery (Medical 30)
Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy; cholecystectomy; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma; thyroidectomy; thoracotomy; cavernous hemangioma.
Genitourinary (Urology) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia
Thoracic Surgery (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectomy; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection: hemostasis; thoracotomy.
Gynecology (GYN) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum.
Pulmonology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.
Ophthalmology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endo-nasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty.
Orthopedics (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: Open: Dissect and coagulate.
Otolaryngology (ENT) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy; Laryngotracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy.
In addition, at 808 nm and 940 nm wavelengths, the Quanta system Diode Medical Laser Family is intended for the following use:
Urology (Medical 30):
Lesions of external genitalia; Circumcision; Condyloma; Bladder tumors; Bladder neck incisions; Vaporization of the prostate
Neurosurgery (Medical 30):
Percutaneous Disc Decompression; Discectomy; Hemostasis in conjunction with meningiomas
Arthroscopy (Medical 30): Chondromalacia; Synovectomy; Menisectomy
Pulmonary Surgery (Medical 30);
Endoscopic pulmonary applications; Tracheal bronchial lesions; Benign and malignant pulmonary or stricture
Cardiac Surgery (Medical 30): Coagulation and haemostasis of cardiac tissue
Dermatology/Aesthetics (Medical 30):
Photocoagulation of vascular & dermatological lesions of the face and extremities; Photocoagulation of telangiectasia, veinulectasias of the legs and face; Treatment of reticular veins and branch varicosities; Pyogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas; Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Chery angioma, Hemangioma, Port wine stains, angiokeratoma, and benign ipidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.; Dermatology surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment; Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne treatment; Hair removal of unwanted hair from skin type I-V;
Plastic Surgery (Medical 30):
Cut, coagulation & vaporization; Blepharoplasy
Vascular Surgery (Medical 30):
Endoluminal or endovenus laser surgery for saphenous incompetent veins.
Dental applications (Medical 30, 6, 4):
Frenectomy; Frenotomy; Biopsy; Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening
808 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Quanta System Diode Medical Laser Family are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
940 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Quanta System Diode Medical Laser Family (Medical 30) is 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 28-85cc and for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non contact open surgery (with or without a handpiece).
It (Medical 30) is also intended for use in the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.
It (Medical 30) is also indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.
The Quanta System Diode Laser Family (Medical 30, 6, 4) is also 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 biopsiesExposure 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; Pulpotomy; 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 Diode Laser Family (Medical 30, 6, 4) is also 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.)
Model 30 is indicated for Surgical, Dermatological, Dental and Endovascular applications.
Model 6 and Model 4 are indicated for Dental and Surgical applications.
Product codes
OCL, GEX
Device Description
The 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 external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the Diode Laser Family incorporates several safety features, including a remote interlock and a key switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue in medical specialties including: gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery, esophageal, colonoscopy, spinal cord, cortex, varicose veins, superficial reflux of the greater saphenous vein, appendectomy, cholecystectomy, bowel, mastectomy, reduction mammoplasty, breast, rectal, anal, hemorrhoidectomy, colectomy, liver, condyloma, thyroidectomy, thoracotomy, cavernous hemangioma, prostate, bladder, urethra, lymphadenectomy, external genitalia, pulmonary, blebs, bullae, pericardiectomy, mediastinal, thoracic, adhesions, endometrial, endometriosis, hysterectomy, uterosacral nerve, myomectomy, ovarian, tubal, fimbrioplasty, cervix, vulvar, vaginal, acuminata, perineal, intrauterine, fibroids, polyps, septum, tracheal, bronchial, Oculoplastics, DCR, nose, tumor, eyelid, blepharoplasty, orthopedic, Nasal, Sinus, turbinate, polypectomy of nose and nasal passages, ethmoidectomy, meatal antrostomy, Laryngotracheal, vocal cord/fold, arytenoidectomy, tracheal, Oropharyngeal, uvulopalatoplasty, tonsillectomy, tonsil, hemi glossectomy, Head & Neck, oral, subfacial, parathyroidectomy, thyroidectomy, Disc, meningiomas, Chondromalacia, Synovectomy, Menisectomy, cardiac tissue, vascular & dermatological lesions of the face and extremities; telangiectasia, veinulectasias of the legs and face; reticular veins and branch varicosities; Pyogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas; Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Chery angioma, Hemangioma, Port wine stains, angiokeratoma, benign ipidermal pigment lesions as lentigines. Epidermal nevi, spider nevi; Condyloma acuminate, warts, non malignant skin tumors, semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers, Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne, Hair, saphenous incompetent veins, oral soft tissue including marginal and inter-dental gingival and epithelial lining of free gingival
Indicated Patient Age Range
men over the age of 50 (for BPH treatment)
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PhotoMedex, Inc.'s LaserPro Surgical Diode Laser System (K042211), Diomed, Inc. EVLT Kit and DPlus Lasers (K041957), BioLase Technology, Inc EZLase Dental Diode Laser system (K061898), INTERmedic Arfran, S.A. INTERmedic Diode Laser Family (K053540), Dornier MedTech America, Inc Dornier Diode Laser Family (K020339)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K072034
SEP 20 2007
510(k) SUMMARY Quanta System's Diode Medical Laser Family
Title:
| Submitter: | Quanta System SpA
via IV Novembre, 116
21058 Solbiate
Olona VA / Italy |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Isabella Carrer
Medical Division Manager |
| Date Prepared: | May 8, 2007 |
| Device Trade Name: | Quanta System Diode Medical Laser Family |
| Common Name: | Laser surgical instrument for use in general and plastic
surgery and in dermatology |
| Classification
Name: | Instrument, surgical, powered, laser
GEX
21 C.F.R. 878.4810 |
| Predicate Devices: | PhotoMedex, Inc.'s LaserPro Surgical Diode Laser
System (K042211)
Diomed, Inc. EVLT Kit and DPlus Lasers
(K041957)
BioLase Technology, Inc EZLase Dental Diode
Laser system (K061898)
INTERmedic Arfran, S.A. INTERmedic Diode
Laser Family (K053540)
Dornier MedTech America, Inc Dornier Diode
Laser Family (K020339) |
| Intended Use /
Indications for Use: | 808 nm, 940 nm, 980nm Wavelengths
The Quanta System Diode Medical Lasers Family, (and
the fiber delivery systems and accessories used to
deliver laser energy), are indicated for use in surgical
applications requiring the ablation, vaporization,
excision, incision, and coagulation of soft tissue in
medical specialties including: gastroenterology, general
surgery, genitourinary surgery (urology), gynecology
(GYN), neurosurgery, otolaryngology (ENT),
orthopedics, ophthalmology, pulmonology, and thoracic |
1
surgery.
The Quanta System Diode Medical Lasers Family are indicated for use in the performance of specific surgical applications in gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics. ophthalmology, pulmonology, and thoracic surgery as follows:
Gastroenterology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy.
Neurosurgery (Medical 30, 6)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex.
General Surgery (Medical 30)
Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy; cholecystectomy; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma; thyroidectomy; thoracotomy; cavernous hemangioma.
Genitourinary (Urology) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and
2
malignant lesions of external genitalia
Thoracic Surgery (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectomy; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection: hemostasis; thoracotomy.
Gvnecology (GYN) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum.
Pulmonology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.
Ophthalmology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endo-nasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty.
Orthopedics (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: Open: Dissect and coagulate.
3
Otolaryngology_(ENT) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy; Laryngotracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy.
In addition, at 808 nm and 940 nm wavelengths, the Quanta system Diode Medical Laser Family is intended for the following use:
Urology (Medical 30):
Lesions of external genitalia; Circumcision; Condyloma; Bladder tumors; Bladder neck incisions; Vaporization of the prostate
Neurosurgery (Medical 30):
Percutaneous Disc Decompression; Discectomy; Hemostasis in conjunction with meningiomas
Arthroscopy (Medical 30): Chondromalacia; Synovectomy; Menisectomy
Pulmonary Surgery (Medical 30);
Endoscopic pulmonary applications; Tracheal bronchial lesions; Benign and malignant pulmonary or stricture
Cardiac Surgery (Medical 30): Coagulation and haemostasis of cardiac tissue
Dermatology/Aesthetics (Medical 30):
Photocoagulation of vascular & dermatological lesions of the face and extremities; Photocoagulation of telangiectasia, veinulectasias of the legs and face; Treatment of reticular veins and branch varicosities; Pyogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas;
4
Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Chery angioma, Hemangioma, Port wine stains, angiokeratoma, and benign ipidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.; Dermatology surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment; Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne treatment; Hair removal of unwanted hair from skin type I-V;
Plastic Surgery (Medical 30):
Cut, coagulation & vaporization; Blepharoplasy
Vascular Surgery (Medical 30):
Endoluminal or endovenus laser surgery for saphenous incompetent veins.
Dental applications (Medical 30, 6, 4):
Frenectomy; Frenotomy; Biopsy; Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening
808 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Quanta System Diode Medical Laser Family are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
940 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of
5
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 28-85cc and for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non contact open surgery (with or without a handpiece).
It (Medical 30) is also intended for use in the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.
It (Medical 30) is also indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.
The Quanta System Diode Laser Family (Medical 30, 6, 4) is also 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 biopsiesExposure 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; Pulpotomy; 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 Diode Laser Family (Medical 30, 6, 4) is also 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.)
6
Model 30 is indicated for Surgical, Dermatological, Dental and Endovascular applications.
Model 6 and Model 4 are indicated for Dental and Surgical applications.
The 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 external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the Diode Laser Family incorporates several safety features, including a remote interlock and a key switch..
The Quanta System Diode Medical Laser Family is as safe and effective as the predicate devices. The Diode Medical Laser Family has the same intended uses, and similar indications for use, technological characteristics, and principles of operation as the predicates. The minor technological differences between the Diode Medical Laser Family and its predicates raise no new issues of safety or effectiveness. Thus, the Diode Medical Laser Family is substantially equivalent.
Technological Characteristics:
Substantial Equivalence:
7
Image /page/7/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2008
Quanta System, S.P.A. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, Northwest Buffalo, MN 55313
Re: K072034
Trade/Device Name: Quanta System Diode Medical Laser Family: Models 4, 6, and 30 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: August 28, 2007 Received: August 29, 2007
Dear Mr. Job:
This letter corrects our substantially equivalent letter of September 20, 2007.
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 (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 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.
8
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); good manufacturing practice requirements as set 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 continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
O'Mallein
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use Statement
510(k) Number (if known) :
Device Name:
Quanta System Diode Medical Laser Family: Models 4, 6, and 30
Indications For Use:
808 nm, 940 nm, 980 nm Wavelengths
The Quanta System Diode Medical Lasers Family, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryneology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery,
The Quanta System Diode Medical Lasers Family are indicated for use in the performance of specific surgical applications in gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), orthopedics, ophthalmology, pulmonology, and thoracic surgery as follows:
Gastroenterology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy.
Neurosurgery (Medical 30,6)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex.
General Surgery (Medical 30)
Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy; cholecystectomy; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma;
thyrgidectorny; thoracotomy; cavernous hemangioma.
Division Sign-Off
Page 1 of 5
Division of General, Restorative, and Neurological Devices
510(k) Number
10
Genitourinary (Urology) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia
Thoracic Surgery (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectomy; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection; hemostasis; thoracotomy.
Gvnecology (GYN) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN)
procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum.
Pulmonology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions.
Ophthalmology (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endo-nasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty.
Orthopedics (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures, Applications include: Open: Dissect and
coagulate.
Mark A. Miller
Page 2 of 5
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
11
Otolaryngology_(ENT) (Medical 30)
The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectorny and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectomy; meatal antrostomy; Laryngo-tracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectomy; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy.
In addition, at 808nm and 980nm wavelengths, the Quanta system Diode Medical Laser family is intended for the following use:
Urology (Medical 30):
Lesions of external genitalia; Circumcision; Condyloma; Bladder turnors; Bladder neck incisions; Vaporization of the prostate
Neurosurgery (Medical 30):
Percutaneous Disc Decompression; Discectomy; Hemostasis in conjunction with meningiomas
Arthroscopy (Medical 30):
Chondromalacia; Synovectomy; Menisectomy
Pulmonary Surgery (Medical 30):
Endoscopic pulmonary applications; Tracheal bronchial lesions; Benign and malignant pulmonary or stricture
Cardiac Surgery (Medical 30):
Coagulation and haemostasis of cardiac tissue
Dermatology/Aesthetics (Medical 30):
Photocoagulation of vascular & dermatological lesions of the face and extremities; Photocoagulation of telangiectasia, veinulectasias of the legs and face; Treatment of reticular veins and branch varicosities; Pyogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas; Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Chery angioma, Hemangioma, Port wine stains, angiokeratoma, and benign ipidermal pigment lesions as lentigines. Epidermal nevi, spider nevi ; Dermatology surgery: Condyloma acuminate, warts, small non malignant
Mark A. Muller
Page 3 of 5
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number.
12
skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment; Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne treatment; Hair removal of unwanted hair from skin type I-V;
Plastic Surgery (Medical 30):
Cut, coagulation & vaporization; Blepharoplasy
Vascular Surgery (Medical 30):
Endoluminal or endovenus laser surgery for saphenous incompetent veins.
Dental applications (Medical 30, 6, 4):
Frenectomy; Frenotomy; Biopsy; Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening
808 nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Quanta System Diode Medical Laser Family are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
940nm Wavelength
The Quanta System Diode Medical Laser Family (Medical 30) is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
The Quanta System Diode Medical Laser Family (Medical 30), is 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 28-85cc and for cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopes), or in incision/excision, vaporization, ablation and coagulation of soft tissue in contact or non contact open surgery (with or without a handpiece).
It (Medical 30) is also intended for use in the treatment and/or removal of vascular lesions (tumors) and for the removal of unwanted hair.
Mark A. Milliken
Page 4 of 5
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K07203
510(k) Number
13
It (Medical 30) is also indicated for use in medicine and surgery, in the following medical specialties: Urology, Plastic Surgery, General Surgery, Dermatology, Gynecology, Pulmonary Surgery, Gastroenterology, ENT and Radiology.
The Quanta System Diode Laser Family (Medical 30, 6, 4) is also 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 biopsiesExposure of unerupted teeth; Fibroma removal; Frenectomy; Gingival troughing for crown impressions; Gingivectorny; Gingivoplasty; Gingival incision and excision; Haemostasis and coagulation; Implant recovery; Incision and drainage of abscess; Leukoplakia; Operculectomy; Oral papillectomies; Pulpotomy; 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 Diode Laser Family (Medical 30, 6, 4) is also 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, 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.)
Prescription Use: > AND/OR (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use: (Part 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office off Device Evaluation (ODE)
Mash A. Millan
Page 5 of 5
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
72039
510(k) Number