510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Greenlight HPS Series Surgical Laser System & Accessories

K062719510(k) TraditionalCleared Dec 1, 200680-day reviewClass II21 CFR 878.4810Recalls 5

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

Laserscope · GEX Powered Laser Surgical Instrument

Cleared on Dec 1, 2006 after an 80-day review. The FDA summary names its predicate without a number. 2 of the 39 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it. It has been recalled 5 times.

Decided
Dec 1, 2006
Review
80 days
Class
Class II
Product code
GEX
Recalls
5
Predicates
0

38 later devices descend from it, 4 citing it directly. 2 of the 39 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2009: 3 descendants cleared2010: 2 descendants cleared2018: 1 descendant cleared2013: 4 descendants cleared2017: 5 descendants cleared, 1 with a Class I recall12024: 2 descendants cleared2021: 1 descendant cleared2012: 1 descendant cleared2015: 2 descendants cleared, 1 with a Class I recall12016: 1 descendant cleared2014: 1 descendant cleared2020: 4 descendants cleared2023: 2 descendants cleared2025: 4 descendants cleared2026: 4 descendants cleared2022: 1 descendant cleared20052010201520202025
  1. This deviceK062719 Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope · 2006
  2. Descendant · cites it directly · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
  3. Descendant · 2 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
  4. Descendant · 3 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
  5. Descendant · 3 generations on · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
  6. Descendant · 3 generations on · 18 of its ownK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

2009: 32010: 22012: 12013: 42014: 12015: 22016: 12017: 52018: 12020: 42021: 12022: 12023: 22024: 22025: 42026: 4
2009high 5 (2017) · low 0 (2011)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 38 · See all
  • K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009 · cites it directly22descendants
  • K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · 2 generations on21descendants
  • K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 3 generations on19descendants
  • K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · 3 generations on19descendants
  • K141983Neuroblate SystemMonteris Medical Corp. · 2014 · 3 generations on18descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062719Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope2006—
+1K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,2009—
+2K120561Neuroblate SystemMonteris Medical, Inc.20131
+3K131955Neuroblate (TM) SystemMonteris Medical, Inc.20132
+3K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc.20131
+3K141983Neuroblate SystemMonteris Medical Corp.20142

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200930
201020
201210
201340
201410
201521
201610
201751
201810
202040
202110
202210
202320
202420
202540
202640
FIG. 1 — Lineage of K062719, 2006–2026Source: 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.

2 devices in this family have a Class I recall. 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
*—Laserscope Lyra Surgical Laser System & Accessories
Named without a submission number
—
*—Laserscope Lyra GTM Surgical Laser System & Accessories
Named without a submission number
—
*—800 Series Surgical Laser System & Accessories
Named without a submission number
—
*—Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength…
Named without a submission number
—
*—Laserscope Microbeam IV Micromanipulator
Named without a submission number
—

What descends from it? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K081509Monteris Medical Autolitt Laser ProbeMonteris Medical,200922
K090962Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TMQuanta System Spa20098
K100746Fiber OneAmerican Medical Systems20102
K092735Greenlight XPS Laser SystemAmerican Medical Systems, Inc.20092

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 31, 2022Class IIIZ-1392-2022Software Manufacturing/Software DeploymentSeveral complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may…
Dec 11, 2012Class IIZ-0700-2013Nonconforming Material/ComponentDuring electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard.
Jan 22, 2010Not classifiedZ-2502-2010Labeling mix-upsProduct may be packed with incorrect external or internal labels and/or missing product insert.
Jun 18, 2007Not classifiedZ-0131-2008Process designControl knob break: The knob used to finely control the direction of the laser energy may break.
Apr 17, 2007Not classifiedZ-0130-2008Process designComponent missing: Some products were issued without thermal protection switches.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
  • K171255Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K081509 (Monteris Medical,, 2009) has gone furthest, with 22 descendants of its own.

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 GreenLight HPS TM Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. 532nm Applications General Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and…

Read the full statement (666 words)

The GreenLight HPS TM Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.

532nm Applications

General Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and Ablating of Soft tissue as well as in Endoscopic (e.g. laparoscopic) or open surgeries.

Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; Esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; Gastrointestinal hemostasis (including Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal Ulcers, Non-bleeding Ulcers, Gastric erosions); Gastrointestinal Tissue ablation (Benign and Malignant neoplasm, Angiodysplasia, Polyps, Ulcer, Colitis, Hemorrhoids).

Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: Endometriosis; Cervical, vulvar, and vaginal intraepitheal neoplasia; Condyloma Acuminata; Uterine Septum; Intrauterine adhesions; Submucosal fibroids.

Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.

Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.

Opthamology: Post-vitrectomy endophotocoagulation of the retina.

Plastic Surgery: Vaporizing, Coagulating, Incising, Excising, debulking, and ablating of soft tissue in endoscopic and open procedures.

Spinal Surgery: Percutaneous lumbar diskectomy.

Thoracic Surgery: Vaporizing, Coagulating, Incising, Excising, Debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.

Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including treatment of: Bladder; Urethral & Ureteral Tumors; Condylomas; Lesions of external genitalia;Urethral & penile; Hemangioma; Urethral Strictures; Bladder Neck Obstructions; and, when used at 532nm it is intended to hemostatically vaporize prostate tissue of men suffering from benign prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer.

1064 nm Applications

Endoscopic/Laparoscopic General Surgery: Cutting, ablation, and/or hemostasis of soft tissue in endoscopic or laparoscopic general surgery applications, including but not limited to: Cholecystectomy, Appendectomy, Vagotomy, Pyloromyotomy.

Soft tissue general surgery applications: Skin incision; Tissue dissection; Excision of external tumors and lesions; complete or partial resection of internal organs, tumors, lesions; Tissue ablation; Vessel Coagulation.

Gastroenterology: Tissue ablation and hemostasis inthe gastrointestinal tract; Esophageal neoplastic obstructions including Squamous cell carcinoma and Adenocarcinoma;

Gastroenterology (contd.): Gastrointestinal hemostasis including: Varices, Espohagitis, Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal ulcers, non-bleeding ulcers, Gastric erosions; Gastrointestinal tissue ablation including: Benign and malignant neoplasm; Angiodysplasia; Polyps; Ulcer; Colitis; Hemorrhoids.

Gynecology: Treatment of menorrhagia by photocoagulation of the endometrial lining of the uterus; Ablation of endometrial implants and/or peritoneal adhesions; Soft tissue excisional procedures, such as excisional conization of the cervix; intra-uterine gynecologic procedures where cutting, ablation and/or vessel coagulation may be indicated including Submucous fibroids, Benign endometrial polyps, Uterine septum.

Head and Neck/Otorhinolaryngology (ENT): Tissue incision, excision, ablation, and vessel hemostasis.

Hemostasis during Surgery: Adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic (e.g. laparoscopic) and open procedures.

Neurosurgery: Hemostasis for: Pituitary Tumor; Meningioma; Hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.

Oculoplastics: Incision, Excision, Vaporization and/or coagulation of tissues in Oculoplastic procedures such as: Operations on the lacrimal system; Operation on the eyelids; Removal of biopsy or orbital tumors; Enucleation on eyeball; Exteneration of orbital contents.

Orthopedics: Cutting, ablation, and/or hemostasis of intra-articular tissue in Orthopedic surgical and arthroscopic applications.

Plastic Surgery: Cutting (incision/excision), coagulating, and vaporizing of soft tissue.

Pulmonary Surgery: Palliative treatment of benign and malignant pulmonary airway obstructions, including: Squamous Cell Carcinoma; Adenocarcinoma; Carcinoid; Benign Tumors; Granulomas; Benign Strictures.

Thoracic Surgery: Cutting (incision/excision), coagulating, and vaporizing of soft tissue. Thoracic applications including, but not limited to: Isolation of vessels for endarterectomy and/or by-pass grafts; Wedge Resections; Thoractomy; Formation of Pacemaker pockets.

Vaporization, coagulation, incision/excision, debulking, and ablation of lung tissue (Thoracoscopy).

Urology: : Urological Surgery (ablation, vaporization, incision, excision and coagulation of soft tissue) including: removal of superficial baldder tumors; removal of invasive bladder carcinoma; removal of benign or malignant lesions of the external genitalia including condylomas; treatment of urethral strictures; treatment of vascularities of the bladder wall; prostatectomy.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K062719: Greenlight HPS Series Surgical Laser System & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062719

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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