# K072034: Diode Medical Laser Family, Models 4, 6, 30

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Sep 20, 2007 after 57 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 169 ancestors in all.
263 later devices descend from it; 7 cite it directly.
0 of 433 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042211: Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems, Surgical Laser Technologies, Inc. (2004) Summary page 1.
- K041957: Evlt Kit and the D15PLUS and D30PLUS Diode Lasers, Diomed, Inc. (2004) Summary page 1.
- K061898: Ezlase, Biolase Technology, Inc. (2007) Summary page 1.
- K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene, Intermedic Arfran, SA (2006) Summary page 1.
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System, Dornier Medtech America, Inc. (2002) Summary page 1.

## Most influential descendants
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## 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, 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. 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. 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; 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 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 (Medical30): 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 sarcomn. Warty leucoplasy and ulcers debridmnent; Seborrheic keratosis; Mixoid cyst; Papillary varix; Acne treatment; Hair removal of unwanted hair from skin type IV; 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; Pulpotorny as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening 808 rnm 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 endlovascular 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 endloscopic 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; 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 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.)

Source page: https://510kreport.com/device/K072034
Methodology: https://510kreport.com/methodology