# K100558: Quanta Diode Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Jul 22, 2010 after 143 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: 17 generations back to K943450 (1995). 352 ancestors in all.
68 later devices descend from it; 14 cite it directly.
0 of 421 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072034: Diode Medical Laser Family, Models 4, 6, 30, Quanta System Spa (2007) Summary page 1.
- K083613: Quanta System Polysurge Diode Laser Family, Quanta System Spa (2008) Summary page 1.
- K091534: Lightlas Model 532, Lightmed Corp. (2009) Summary page 1.
- K053604: Wavelight Idas, Wavelight Laser Technologie AG (2006) Summary page 1.
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser, Biolitec, Inc. (2009) Summary page 1.

## Most influential descendants
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (2010), 46 descendants of its own
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (2011), 26 descendants of its own
- K120810: Fiberoptic Laser Delivery System (2012), 24 descendants of its own
- K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe (2013), 23 descendants of its own
- K112253: Ceralas 147NM Diode Laser System (2011), 18 descendants of its own

## 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. LASER 808nm and 980nm Urology: - Lesions of external genitalia - Circumcision - Condyloma - Bladder tumors - Bladder neck incisions - Vaporization of the prostate General Surgery: - Rectal and anal hemorrhoidectomy - Appendectomy (open and laparoscopic) - Bowel resection (open and laparoscopic) - Colectomy - Liver resection - Resection of organs - Thyroidectomy - Adhesiolysis - Hepatobiliary tumors - Thoracotomy - Cholecystectomy (open and laparoscopic) - Condyloma - 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 and malignant pulmonary obstruction Otolaryngology ENT: - Removal of benign lesions from the ear, nose and throat - Excision of carcinoma of the larynx - Incision and excision of carcinoma in situ - Neck dissection - Laryngeal papillomectomy - Removal of vocal cord/fold nodules, polyps and cyst Dental Application: - Frenectomy - Frenotomy - Biopsy - Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening Pulmonary Surgery: - Endoscopic pulmonary applications - Tracheal bronchial lesions - Benign and malignant pulmonary or stricture Cardiac Surgery: - Coagulation and hemostasis of cardiac tissue Dermatology/Aesthetics: - Photocoagulation of vascular & dermatological lesions of the face and extremities - Photocoagulation of telangiectasia, veinulectasia of the legs and face - Treatment of reticular veins and branch varicosities - Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas - Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi. - Dermatological surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment. - Seborrheic keratosis - Mixoid cyst - Papillary varix - Acne treatment - Hair removal of unwanted hair from skin type I-V Plastic Surgery: - Cut, coagulation & vaporization - Resurfacing non - Blepharoplasty Vascular Surgery: - Endoluminal or endovenous laser surgery for saphenous incompetent veins LASER 940nm 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 superficial vein 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; 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 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 larynx - Laryngeal papillomectomy - Excision and vaporization of herpes simplex I and II - Neck dissection Arthroscopy Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include: - Menisectomy - Synovectomy - Chondromalacia Gastroenterology Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: - Hemostasis of upper and lower GI bleeding - Excision and vaporization of colorectal carcinoma - Excision of polyps General Surgery, Dermatology, Plastic Surgery and Podiatry Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include: - Matrixectomy - Excision of neuromas - Excision of periungual and subungual warts - Excision of plantar warts - Excision of keloids - Liver resection - Excision of cutaneous lesions - 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 - Herniorrhaphy - Adhesiolysis - Parathyroidectomy - Laparoscopic cholecystectomy - Thyroidectomy - Resection of organs - Debridement of wounds - Photocoagulation of teleangectasia of the legs and face - Photocoagulation of vascular lesions of the face and extremities - Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux. - Treatment of reticular veins and branch varicosities Urology Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include: - Vaporization of urethral tumors - Release of urethral stricture - Removal of bladder neck obstruction - Excision and vaporization of condyloma - Lesions of external genitalia - Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) Gynecology Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: - Endometrial ablation - Excision or vaporization of condylomata acuminata - Vaporization of cervical intraepithelial neoplasia - Cervical conization - Menorrhagia Neurosurgery Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with meningiomas 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, vestibuloplasty, 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 * Submucous 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 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 System is further indicated for laser assisted lipolysis. 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) - 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 - Duodenal 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) - 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: - Cholecystectomy - 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 - Myringotomy - Lysis of adhesions - Control of bleeding - Removal of acoustic neuromas - Soft tissue adhesion in micro/macro otologic procedures. Dermatology: - Vascular lesion - Pigmented lesion

Source page: https://510kreport.com/device/K100558
Methodology: https://510kreport.com/methodology