510(k) · Cleared
ClearedDoctor Surgery Diode Lasers Family
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lambda S.P.A. · GEX Powered Laser Surgical Instrument
Cleared on Sep 28, 2010 as substantially equivalent to K063396 (Lasering S.R.L., 2007) and 10 other predicates after a 71-day review. Its family tree reaches back 18 generations to 1995. 7 later devices descend from it.
- Decided
- Sep 28, 2010
- Review
- 71 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 11
Its longest line of descent runs back 18 generations to K943450 (1995). 369 ancestors in all, the oldest K771218 (1978). 7 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- 1 generation backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- This deviceK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
- Descendant · cites it directly · 6 of its ownK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
- Descendant · 2 generations on · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK251077 JOULE 1064nm System and AccessoriesSciton, Inc · 2025
- Descendant · 3 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK191349 980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
- 1 generation backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
- This deviceK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013 · cites it directly6descendants
- K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · 2 generations on3descendants
- K251077JOULE 1064nm System and AccessoriesSciton, Inc · 2025 · 2 generations on0descendants
- K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd. · 2025 · 3 generations on0descendants
- K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810 | A.R.C Laser GmbH | 2008 | — |
| −1 | K091562 | Doctor Smile a-810 and B-980 Lasers | Lambda Scientific Spa | 2009 | — |
| 0 (this device) | K102036 | Doctor Surgery Diode Lasers Family | Lambda S.P.A. | 2010 | — |
| +1 | K122567 | Joule 810/940/980 Multi-Platform System | Sciton, Inc | 2013 | — |
| +2 | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
| +2 | K251077 | JOULE 1064nm System and Accessories | Sciton, Inc | 2025 | — |
| +3 | K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems… | Wuhan Dimed Laser Technology Co., Ltd. | 2025 | — |
| +3 | K191349 | 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 18 | 0 |
| 1996 | 24 | 0 |
| 1997 | 29 | 0 |
| 1998 | 25 | 0 |
| 1999 | 21 | 0 |
| 2000 | 29 | 0 |
| 2001 | 32 | 0 |
| 2002 | 36 | 0 |
| 2003 | 29 | 0 |
| 2004 | 20 | 0 |
| 2005 | 12 | 0 |
| 2006 | 7 | 0 |
| 2007 | 9 | 0 |
| 2008 | 7 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (11)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063396 | Velure Family of Diode Lasers and Delivery Device AccessoriesSummary page 1…Doctor Diode Laser Family: - Velure Family of Diode Laser (K063396) - Quanta System Polysurge Diode Laser Family (K083613)… | 2007 |
| * | K083613 | Quanta System Polysurge Diode Laser FamilySummary page 1…- Velure Family of Diode Laser (K063396) - Quanta System Polysurge Diode Laser Family (K083613) - Doctor Smile A-81 0, 8980 Lasers (K091562)… | 2008 |
| * | K091562 | Doctor Smile a-810 and B-980 LasersSummary page 1…Quanta System Polysurge Diode Laser Family (K083613) - Doctor Smile A-81 0, 8980 Lasers (K091562) - Arc Laser GmbH Fox Q-81O, Q-980, Q-1064 (K073322)… | 2009 |
| * | K073322 | Fox 1-980, Fox Q-1064, Fox-Q-810Summary page 1…- Doctor Smile A-81 0, 8980 Lasers (K091562) - Arc Laser GmbH Fox Q-81O, Q-980, Q-1064 (K073322) - Biolase Eziase® £KO82938)… | 2008 |
| * | K082938 | Ezlase | 2008 |
| * | K081214 | Styla Microlaser and StylaorthoSummary page 1…- Biolase Eziase® £KO82938) - Styla MicrolaserT (K081214) - Odissey navigator (K062258)… | 2008 |
| * | K062258 | Genesis Diode LaserSummary page 1…- Styla MicrolaserT (K081214) - Odissey navigator (K062258) - Sirona Sirolaser (K053161)… | 2007 |
| * | K053161 | SirolaserSummary page 1…- Odissey navigator (K062258) - Sirona Sirolaser (K053161) - Kayo Gentleray 980 (K072262)… | 2006 |
| * | K072262 | Gentleray 980 Diode Laser SystemSummary page 1…- Sirona Sirolaser (K053161) - Kayo Gentleray 980 (K072262) - Ceralas 980 (K072779)… | 2007 |
| * | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25Summary page 1…- Kayo Gentleray 980 (K072262) - Ceralas 980 (K072779) ClGaros Nano Dental Laser System (K081652)… | 2008 |
| * | K081652 | Claros Nano Dental Laser SystemSummary page 1…- Ceralas 980 (K072779) ClGaros Nano Dental Laser System (K081652) __ Product description Doctor Diode Laser Family are… | 2008 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122567 | Joule 810/940/980 Multi-Platform System | 2013 | 6 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 17 of the 369 ancestors have a recall of any class.
- Of its descendants, K122567 (Sciton, Inc, 2013) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K063396.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (2,072 words)
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102036: Doctor Surgery Diode Lasers Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102036
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026