# K102036: Doctor Surgery Diode Lasers Family

- Pathway: 510(k) (Abbreviated)
- Applicant: Lambda S.P.A.
- Decided: Sep 28, 2010 after 71 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: 18 generations back to K943450 (1995). 369 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 377 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063396: Velure Family of Diode Lasers and Delivery Device Accessories, Lasering S.R.L. (2007) Summary page 1.
- K083613: Quanta System Polysurge Diode Laser Family, Quanta System Spa (2008) Summary page 1.
- K091562: Doctor Smile a-810 and B-980 Lasers, Lambda Scientific Spa (2009) Summary page 1.
- K073322: Fox 1-980, Fox Q-1064, Fox-Q-810, A.R.C Laser GmbH (2008) Summary page 1.
- K082938: Ezlase, Biolase Technology, Inc. (2008)
- K081214: Styla Microlaser and Stylaortho, Zap Lasers, LLC (2008) Summary page 1.
- K062258: Genesis Diode Laser, Ivoclar Vivadent, Inc. (2007) Summary page 1.
- K053161: Sirolaser, Sirona Dental Systems GmbH (2006) Summary page 1.
- K072262: Gentleray 980 Diode Laser System, Kavo America (2007) Summary page 1.
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.
- K081652: Claros Nano Dental Laser System, Elexxion AG (2008) Summary page 1.

## Most influential descendants
- K122567: Joule 810/940/980 Multi-Platform System (2013), 6 descendants of its own
- K151890: Medical Diode Laser Systems (2015), 3 descendants of its own
- K251077: JOULE 1064nm System and Accessories (2025), 0 descendants of its own
- K252063: Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN) (2025), 0 descendants of its own
- K191349: 980nm Diode Laser Therapy Device (2019), 0 descendants of its own

## Indications for use
Doctor Diode Laser Family including Doctor Smile, Doctor Surgery and Helios are available at 810 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w; at 940 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w; at 980 wavelength with variable power of 500mw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w and at 1064 wavelength with variable power of 500maw, 2w, 2,5w, 5w, 7w, 8w, 10w and 15w (and their delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cuffing and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist indluding: 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. Doctor Diode Laser Family at 810nm's wavelength: Dental application: - 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 papillectomnies, 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. 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.). Light activation of whitening/bleaching material. Doctor Diode Laser Family at 810nm and 980nm's wavelength Urology: - Lesions of external genitalia - Circumcision - Condyloma - Bladder tumors - Bladder neck incisions - Vaporizations 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 laparscopic) - 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 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 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 pigments 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 - Blepharopasty Vascular Surgery: - Endoluminal or endovenous laser surgery for saphenous incompetent veins Doctor Diode Laser Family at 940nm wavelength: The Doctor 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, Dentistry. The Doctor 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 Doctor Diode Laser Eamily(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 Doctor 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 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 Doctor 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; Sulculhr 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). Doctor Diode Laser Family at 980nm wavelength: The Doctor 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 the 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, abd endovenolus occlusion of the greater saphenous vein. The device is specifically indicated for use as follows: Ear, Nose and Throat and Oral Surgery (Otolaryngology): Hemostasis, incision, excision ablation, coagulation, and vaporization of tissue 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 11 - Neck dissection - Tonsillectomy - Thyroidectomy - Vocal cord polypectomy - Hemiglossectomy - Tracheal stenosis - Oral cavity lesions 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, vaporiztion 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, vaporiztion and hemostasis of rectal pathology - Pilonidal cystectomy - Heriorapphy - 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 urogical tissues. Examples include: - Vaporization of urethral tumors - Release of urethral stricture - Removal of bladder neck obstruction - Excision and vaporization of condyoma - Lesions of external genitalia - Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) Gynecology: Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include: - Endometrial ablation. - Excision or vaporization of condylomata acuminata - Vaporization of cervical intraepithelial neoplasia - Cervical conization - Menorrhagia Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. - Examples include: hemostasis in conjunction with menigiomas. Cardiac Surgery: Hemostasis and coagulation of soft tissue, including cardiac tissue. Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, excision and ablation Examples include: - Tracheobronchial malignancy or stricture - Benign and malignant pulmonary obstruction - Endoscopic pulmonary applications Dental Applications: The Doctor 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: Coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux. Doctor Diode Laser Family at 1064mm wavelength: Dermatology/Plastic Surgery: Photocoagulation: - Colored Vascular Lesions of Skin (only if Argon Laser is unsuccessfuil) Discectomy: Percutaneous Lumbar Discectomy Gastrointestinal: Tissue Ablation: - Benign and malignant Neoplasm - Polyps - Colitis - Ulcers - Aniodysplasia - Hemorrhoids Hemostasis: - Varices - Esophangitis - Esophageal Ulcer 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 Doctor 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: Coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux. Doctor Diode Laser Family at 1064nm wavelength: 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 Prostatectomy: Soft Tissue Coagulation: - Bemgn Prostatic Hyperplasia (BPH Prostatectomy) Pulmonary Surgery Palliative Treatment: - Benign and Malignant Pulmonary Airway Obstructions Dental procedures

Source page: https://510kreport.com/device/K102036
Methodology: https://510kreport.com/methodology