# K062719: Greenlight HPS Series Surgical Laser System & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Dec 1, 2006 after 80 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
38 later devices descend from it; 4 cite it directly.
2 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Laserscope Lyra Surgical Laser System & Accessories: named in the summary without a submission number
- (no number) Laserscope Lyra GTM Surgical Laser System & Accessories: named in the summary without a submission number
- (no number) 800 Series Surgical Laser System & Accessories: named in the summary without a submission number
- (no number) Modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories: named in the summary without a submission number
- (no number) Laserscope Microbeam IV Micromanipulator: named in the summary without a submission number

## Most influential descendants
- K081509: Monteris Medical Autolitt Laser Probe (2009), 22 descendants of its own
- K120561: Neuroblate System (2013), 21 descendants of its own
- K131955: Neuroblate (TM) System (2013), 19 descendants of its own
- K131278: Monteris Medical Neuroblate System (2013), 19 descendants of its own
- K141983: Neuroblate System (2014), 18 descendants of its own

## Recalls of this device
- May 31, 2022 · Class III · Z-1392-2022: 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 la
- Dec 11, 2012 · Class II · Z-0700-2013: 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: Product may be packed with incorrect external or internal labels and/or missing product insert.
- Jun 18, 2007 · Not classified · Z-0131-2008: 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: Component missing: Some products were issued without thermal protection switches.

## Indications for use
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.

Source page: https://510kreport.com/device/K062719
Methodology: https://510kreport.com/methodology