510(k) · Cleared
Recalled · Class II · 2022Greenlight HPS Series Surgical Laser System & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- This deviceK062719 Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope · 2006
- Descendant · cites it directly · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- Descendant · 2 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062719 | Greenlight HPS Series Surgical Laser System & Accessories | Laserscope | 2006 | — |
| +1 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| +2 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +3 | K131955 | Neuroblate (TM) System | Monteris Medical, Inc. | 2013 | 2 |
| +3 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +3 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 1 | 0 |
| 2017 | 5 | 1 |
| 2018 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | 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 384 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2022 | Class III | Z-1392-2022 | Software Manufacturing/Software Deployment | Several 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, 2012 | Class II | Z-0700-2013 | Nonconforming Material/Component | During electrical recertification testing it was found that the Voltage Scaling Board was non-conforming to the IEC 60601-1-2 standard. |
| Jan 22, 2010 | Not classified | Z-2502-2010 | Labeling mix-ups | Product may be packed with incorrect external or internal labels and/or missing product insert. |
| Jun 18, 2007 | Not classified | Z-0131-2008 | Process design | Control knob break: The knob used to finely control the direction of the laser energy may break. |
| Apr 17, 2007 | Not classified | Z-0130-2008 | Process design | Component 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.
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 devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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.
https://510kreport.com/device/K062719 · printed Nov 6, 2026
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