510(k) Report

510(k) · Cleared

Cleared

Vectra Laser System

K060114510(k) TraditionalCleared Apr 7, 200680-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

Xintec Corporation, Dba, · GEX Powered Laser Surgical Instrument

Cleared on Apr 7, 2006 as substantially equivalent to K050824 (Biolitec, Inc., 2005) and 2 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1990. 233 later devices descend from it.

Decided
Apr 7, 2006
Review
80 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K901710 (1990). 3 ancestors in all. 233 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1995: 1 other ancestor2008: 4 descendants cleared2007: 2 descendants cleared2010: 7 descendants cleared2014: 10 descendants cleared2009: 5 descendants cleared2011: 4 descendants cleared2012: 5 descendants cleared2013: 9 descendants cleared2016: 11 descendants cleared2022: 24 descendants cleared2020: 16 descendants cleared2021: 10 descendants cleared2018: 13 descendants cleared2019: 11 descendants cleared2017: 8 descendants cleared2015: 10 descendants cleared2024: 24 descendants cleared2026: 19 descendants cleared2025: 29 descendants cleared2023: 12 descendants clearedK901710 · Optica 120 ND:Yag Surgical Laser System · Xintec Corporation · 19901990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 6 descendants2 generations forward: 12 descendants3 generations forward: 25 descendants4 generations forward: 46 descendants5 generations forward: 53 descendants6 generations forward: 49 descendants7 generations forward: 29 descendants8 generations forward: 9 descendants9 generations forward: 3 descendants10 generations forward: 1 descendant K901710 · Optica 120 ND:Yag Surgical Laser System · Xintec Corporation · 19900+5+10
  1. Root · 1 generation backK901710 Optica 120 ND:Yag Surgical Laser SystemXintec Corporation · 1990
  2. This deviceK060114 Vectra Laser SystemXintec Corporation, Dba, · 2006
  3. Descendant · cites it directly · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  4. Descendant · 2 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
  5. Descendant · 2 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
  6. Descendant · 2 generations on · 121 of its ownK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  7. Descendant · cites it directly · 112 of its ownK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010

Showing 5 of 233 descendants. See all descendants

Descendants cleared per year

2007: 22008: 42009: 52010: 72011: 42012: 52013: 92014: 102015: 102016: 112017: 82018: 132019: 112020: 162021: 102022: 242023: 122024: 242025: 292026: 19
2007high 29 (2025) · low 2 (2007)2026

Most influential descendants

Showing 5 of 233 · See all
  • K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · cites it directly229descendants
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
  • K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 2 generations on177descendants
  • K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009 · 2 generations on121descendants
  • K082230Vectra Plus Laser System and AccessoriesXintec Corporation · 2010 · cites it directly112descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K901710Optica 120 ND:Yag Surgical Laser SystemXintec Corporation1990—
0 (this device)K060114Vectra Laser SystemXintec Corporation, Dba,2006—
+1K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
+2K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—
+2K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009—
+2K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009—
+1K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200840
200950
201070
201140
201250
201390
2014100
2015100
2016110
201780
2018130
2019110
2020160
2021100
2022240
2023120
2024240
2025290
2026190
FIG. 1 — Lineage of K060114, 1990–2026Source: 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? (3)

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
*K050824100W Ceralas D 980 Laser System, Model D100
Summary page 4
…VectraTM Optica M Odyssey TM Ceralas 510K# K901710 510K# 951910 510LgK050824 Wavelength 980nm+ 10% 1064nm+ 10% 2100nm+ 10% 980nm Maximum 10/20/30W; 60W;…
Biolitec, Inc.2005—
*K901710Optica 120 ND:Yag Surgical Laser System
Summary page 4
…INFORMATION Specifications VectraTM Optica M Odyssey TM Ceralas 510K# K901710 510K# 951910 510LgK050824 Wavelength 980nm+ 10% 1064nm+ 10% 2100nm+ 10% 98…
Xintec Corporation1990—
*K951910Odyssey HO:Yag Surgical Laser Systems & Accessories
Summary page 4
…cations VectraTM Optica M Odyssey TM Ceralas 510K# K901710 510K# 951910 510LgK050824 Wavelength 980nm+ 10% 1064nm+ 10% 2100nm+ 10% 980nm Maximum…
Xintec Corporation1995—

Also cleared against K050824: 8 other devices →

What descends from it? (233)

See all 233

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

NumberDeviceApplicantDecidedDescendants
K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229
K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112
K082938EzlaseBiolase Technology, Inc.200850
K140120EPIC 10Biolase, Inc.20141
K073411LiteduoLight Instruments20081
K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K072106 (Biolitec, Inc., 2007) has gone furthest, with 229 descendants of its own.
  • 8 other devices also cite its predicate K050824.

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.

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 device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscope. The device is generally 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, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery…

Read the full statement (639 words)

The device is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscope. The device is generally 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, neurosurgery (peripheral nervous system), pulmonary and cardiothoracic surgery, dental applications, and endovenous 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 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 an 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

Herniorapphy

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 homeostasis of urological, including BPH/prostatic, tissues. Examples include:

Vaporization of uretheral tumors

Release of urethral stricture

Removal of bladder neck obstruction

Excision and vaporization of condyloma

Lesions of external genitalia

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynechological tissue. Examples include:

Endometrial ablation

Excision or vaporization of condylomata acuminate

Vaporization of cervical intraepithelial neoplasia

Cervical conization

Menorrhagia

Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include:

Hemeostasis in conjunction with menigiomas

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

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, vestibulopasty, 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.

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. “K060114: Vectra 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/K060114

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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