510(k) Report

510(k) · Cleared

Cleared

Doctor Surgery Diode Lasers Family

K102036510(k) AbbreviatedCleared Sep 28, 201071-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

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.

Other ancestors, by year clearedDescendants, by year cleared 2008: 7 other ancestors2007: 9 other ancestors2006: 7 other ancestors2005: 12 other ancestors2004: 20 other ancestors2003: 29 other ancestors2002: 36 other ancestors2001: 32 other ancestors2000: 29 other ancestors1999: 21 other ancestors1998: 25 other ancestors1997: 29 other ancestors1994: 18 other ancestors1996: 24 other ancestors1995: 18 other ancestors1990: 4 other ancestors1992: 5 other ancestors1988: 2 other ancestors1993: 11 other ancestors1991: 6 other ancestors1989: 2 other ancestors1981: 1 other ancestor1978: 1 other ancestor1985: 1 other ancestor1982: 1 other ancestor1980: 1 other ancestor2013: 1 descendant cleared2025: 2 descendants cleared2016: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006×3: 3 generations cleared close together, K071295 (2007), K072106 (2007), K073322 (2008) K091562 · Doctor Smile a-810 and B-980 Lasers · Lambda Scientific Spa · 200919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 25 other ancestors3 generations back: 39 other ancestors4 generations back: 33 other ancestors5 generations back: 83 other ancestors6 generations back: 101 other ancestors7 generations back: 43 other ancestors8 generations back: 17 other ancestors9 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 3 descendants K091562 · Doctor Smile a-810 and B-980 Lasers · Lambda Scientific Spa · 2009K073322 · Fox 1-980, Fox Q-1064, Fox-Q-810 · A.R.C Laser GmbH · 2008K072106 · 150W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K071295 · 100W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50
  1. Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 14 generations between
  3. 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  4. 2 generations backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
  5. 1 generation backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
  6. This deviceK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010
  7. Descendant · cites it directly · 6 of its ownK122567 Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013
  8. Descendant · 2 generations on · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
  9. Descendant · 2 generations on · 0 of its ownK251077 JOULE 1064nm System and AccessoriesSciton, Inc · 2025
  10. Descendant · 3 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
  11. Descendant · 3 generations on · 0 of its ownK191349 980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019
Show all 18 generations
  1. Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 4 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  16. 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  17. 2 generations backK073322 Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH · 2008
  18. 1 generation backK091562 Doctor Smile a-810 and B-980 LasersLambda Scientific Spa · 2009
  19. This deviceK102036 Doctor Surgery Diode Lasers FamilyLambda S.P.A. · 2010

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 12015: 12016: 12018: 12019: 12025: 2
2013high 2 (2025) · low 0 (2014)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−18K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−17K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−16K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−15K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−14K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−13K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−12K000944Thermage Thermacool SystemThermage, Inc.2000—
−11K013034Modification to: Thermacool IiaThermage, Inc.2001—
−10K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−9K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−8K030142Thermacool TC SystemThermage, Inc.2003—
−7K031671Polaris WRSyneron Medical, Ltd.2003—
−6K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−2K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH2008—
−1K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa2009—
0 (this device)K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.2010—
+1K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc2013—
+2K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.2015—
+2K251077JOULE 1064nm System and AccessoriesSciton, Inc2025—
+3K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems…Wuhan Dimed Laser Technology Co., Ltd.2025—
+3K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198010
198110
198210
198510
198820
198920
199040
199160
199250
1993110
1994180
1995180
1996240
1997290
1998250
1999210
2000290
2001320
2002360
2003290
2004200
2005120
200670
200790
200870

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201610
201810
201910
202520
FIG. 1 — Lineage of K102036, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K063396Velure Family of Diode Lasers and Delivery Device Accessories
Summary page 1
…Doctor Diode Laser Family: - Velure Family of Diode Laser (K063396) - Quanta System Polysurge Diode Laser Family (K083613)…
Lasering S.R.L.2007—
*K083613Quanta System Polysurge Diode Laser Family
Summary page 1
…- Velure Family of Diode Laser (K063396) - Quanta System Polysurge Diode Laser Family (K083613) - Doctor Smile A-81 0, 8980 Lasers (K091562)…
Quanta System Spa2008—
*K091562Doctor Smile a-810 and B-980 Lasers
Summary 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)…
Lambda Scientific Spa2009—
*K073322Fox 1-980, Fox Q-1064, Fox-Q-810
Summary page 1
…- Doctor Smile A-81 0, 8980 Lasers (K091562) - Arc Laser GmbH Fox Q-81O, Q-980, Q-1064 (K073322) - Biolase Eziase® £KO82938)…
A.R.C Laser GmbH2008—
*K082938EzlaseBiolase Technology, Inc.2008—
*K081214Styla Microlaser and Stylaortho
Summary page 1
…- Biolase Eziase® £KO82938) - Styla MicrolaserT (K081214) - Odissey navigator (K062258)…
Zap Lasers, LLC2008—
*K062258Genesis Diode Laser
Summary page 1
…- Styla MicrolaserT (K081214) - Odissey navigator (K062258) - Sirona Sirolaser (K053161)…
Ivoclar Vivadent, Inc.2007—
*K053161Sirolaser
Summary page 1
…- Odissey navigator (K062258) - Sirona Sirolaser (K053161) - Kayo Gentleray 980 (K072262)…
Sirona Dental Systems GmbH2006—
*K072262Gentleray 980 Diode Laser System
Summary page 1
…- Sirona Sirolaser (K053161) - Kayo Gentleray 980 (K072262) - Ceralas 980 (K072779)…
Kavo America2007—
*K072779Ceralas D 980NM Diode Laser, Models D15 and D25
Summary page 1
…- Kayo Gentleray 980 (K072262) - Ceralas 980 (K072779) ClGaros Nano Dental Laser System (K081652)…
Biolitec, Inc.2008—
*K081652Claros Nano Dental Laser System
Summary page 1
…- Ceralas 980 (K072779) ClGaros Nano Dental Laser System (K081652) __ Product description Doctor Diode Laser Family are…
Elexxion AG2008—

Also cleared against K063396: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136

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 devices

GEX 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

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

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.

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