510(k) Report

510(k) · Cleared

Cleared

Quanta Diode Laser System

K100558510(k) TraditionalCleared Jul 22, 2010143-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

Quanta System Spa · GEX Powered Laser Surgical Instrument

Cleared on Jul 22, 2010 as substantially equivalent to K072034 (Quanta System Spa, 2007) and 4 other predicates after a 143-day review. Its family tree reaches back 17 generations to 1995. 68 later devices descend from it.

Decided
Jul 22, 2010
Review
143 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
5

Its longest line of descent runs back 17 generations to K943450 (1995). 352 ancestors in all, the oldest K771218 (1978). 68 later devices descend from it, 14 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 2 other ancestors2007: 5 other ancestors2006: 6 other ancestors2008: 3 other ancestors2004: 19 other ancestors2002: 36 other ancestors1995: 18 other ancestors1994: 18 other ancestors2005: 12 other ancestors2003: 30 other ancestors2001: 30 other ancestors2000: 28 other ancestors1998: 25 other ancestors1997: 28 other ancestors1999: 17 other ancestors1996: 23 other ancestors1990: 4 other ancestors1988: 2 other ancestors1992: 5 other ancestors1993: 11 other ancestors1991: 6 other ancestors1989: 2 other ancestors1985: 1 other ancestor1981: 1 other ancestor1980: 1 other ancestor1978: 1 other ancestor1982: 1 other ancestor2022: 6 descendants cleared2015: 3 descendants cleared2016: 7 descendants cleared2024: 9 descendants cleared2010: 1 descendant cleared2013: 6 descendants cleared2014: 4 descendants cleared2026: 3 descendants cleared2011: 3 descendants cleared2025: 13 descendants cleared2020: 2 descendants cleared2019: 1 descendant cleared2018: 2 descendants cleared2012: 1 descendant cleared2023: 3 descendants cleared2021: 2 descendants cleared2017: 2 descendants 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 · 2006×2: 2 generations cleared close together, K071295 (2007), K072106 (2007) K083613 · Quanta System Polysurge Diode Laser Family · Quanta System Spa · 200819801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 15 other ancestors3 generations back: 40 other ancestors4 generations back: 44 other ancestors5 generations back: 99 other ancestors6 generations back: 86 other ancestors7 generations back: 37 other ancestors8 generations back: 10 other ancestors 1 generation forward: 14 descendants2 generations forward: 19 descendants3 generations forward: 10 descendants4 generations forward: 6 descendants5 generations forward: 9 descendants6 generations forward: 6 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant K083613 · Quanta System Polysurge Diode Laser Family · Quanta System Spa · 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+5
  1. Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 13 generations between
  3. 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  4. 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  5. 1 generation backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
  6. This deviceK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
  7. Descendant · cites it directly · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
  8. Descendant · 2 generations on · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
  9. Descendant · 3 generations on · 24 of its ownK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
  10. Descendant · 3 generations on · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
  11. Descendant · 2 generations on · 18 of its ownK112253 Ceralas 147NM Diode Laser SystemBiolitec, Inc. · 2011
Show all 17 generations
  1. Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 5 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 4 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 3 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  16. 2 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  17. 1 generation backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
  18. This deviceK100558 Quanta Diode Laser SystemQuanta System Spa · 2010

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2010: 12011: 32012: 12013: 62014: 42015: 32016: 72017: 22018: 22019: 12020: 22021: 22022: 62023: 32024: 92025: 132026: 3
2010high 13 (2025) · low 1 (2010)2026

Most influential descendants

Showing 5 of 68 · See all
  • K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · cites it directly46descendants
  • K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · 2 generations on26descendants
  • K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012 · 3 generations on24descendants
  • K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · 3 generations on23descendants
  • K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc. · 2011 · 2 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−17K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−16K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−15K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−14K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−13K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−12K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−11K000944Thermage Thermacool SystemThermage, Inc.2000—
−10K013034Modification to: Thermacool IiaThermage, Inc.2001—
−9K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−8K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−7K030142Thermacool TC SystemThermage, Inc.2003—
−6K031671Polaris WRSyneron Medical, Ltd.2003—
−5K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−2K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−1K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—
0 (this device)K100558Quanta Diode Laser SystemQuanta System Spa2010—
+1K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc.2010—
+2K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.2011—
+3K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.2012—
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers…Med-Fibers, Inc.2013—
+2K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198010
198110
198210
198510
198820
198920
199040
199160
199250
1993110
1994180
1995180
1996230
1997280
1998250
1999170
2000280
2001300
2002360
2003300
2004190
2005120
200660
200750
200830
200920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201130
201210
201360
201440
201530
201670
201720
201820
201910
202020
202120
202260
202330
202490
2025130
202630
FIG. 1 — Lineage of K100558, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (5)

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
*K072034Diode Medical Laser Family, Models 4, 6, 30
Summary page 1
…Name: Instrument, surgical, powered, laser Predicate Devices: - Quanta System Diode Medical Laser Family (K072034); - Quanta System Polysurge Diode Laser Family (K083613…
Quanta System Spa2007—
*K083613Quanta System Polysurge Diode Laser Family
Summary page 1
…(K072034); - Quanta System Polysurge Diode Laser Family (K083613) - Lightmed LightLas 532 (11091534) - Quantel IDAS (K0536…
Quanta System Spa2008—
*K091534Lightlas Model 532
Summary page 1
…- Quanta System Polysurge Diode Laser Family (K083613) - Lightmed LightLas 532 (11091534) - Quantel IDAS (K053604) - Biolitec Ceralas Multiwavelen…
Lightmed Corp.2009—
*K053604Wavelight Idas
Summary page 1
…(K083613) - Lightmed LightLas 532 (11091534) - Quantel IDAS (K053604) - Biolitec Ceralas Multiwavelength 980/1470nm Diode La…
Wavelight Laser Technologie AG2006—
*K090164Ceralas Multiwavelength 980/1470NM Diode Laser
Summary page 1
…- Quantel IDAS (K053604) - Biolitec Ceralas Multiwavelength 980/1470nm Diode Laser System (K(090164) Intended Use IThe Quanta System QUANTA Diode Laser Family, Indications for Use: including the Q…
Biolitec, Inc.2009—

Also cleared against K072034: 6 other devices →

What descends from it? (68)

See all 68

14 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046
K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517
K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413
K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146
K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136
K160952Alma Diode Tabletop LaserAlma, Ltd.20165
K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244
K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153
K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242
K222701MANTA LaserSqualus Med, Ltd.20222

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 6 companies; a new generation was cleared every 9 months on median.
  • 16 of the 352 ancestors have a recall of any class.
  • Of its descendants, K102755 (Biolitec, Inc., 2010) has gone furthest, with 46 descendants of its own.
  • 6 other devices also cite its predicate K072034.

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?

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…

Read the full statement (2,546 words)

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

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. “K100558: Quanta Diode Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100558

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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