(80 days)
Not Found
No
The summary describes a surgical laser system and its accessories, focusing on its physical components, intended uses, and applications across various medical specialties. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities that would suggest the use of AI/ML technology.
No.
The device is a surgical laser system intended for the incision, excision, vaporization, ablation, and coagulation of soft tissue, which falls under surgical intervention rather than therapeutic treatment.
No
The device is a surgical laser system intended for the incision/excision, vaporization, ablation, and coagulation of soft tissue, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly lists multiple hardware subsystems, including an Optical and Laser resonator System, Electronics and Electrical System, Delivery Devices and Accessories, and a Cooling Sub-system. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "surgical incision/excision, vaporization, ablation and coagulation of soft tissue." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description details a surgical laser system and its components, which are used for performing surgical actions.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens in vitro (outside the body).
The device is a surgical laser system used for therapeutic and procedural purposes in vivo (within the body).
N/A
Intended Use / Indications for Use
The GreenLight HPS™ Surgical Laser System and Accessories is 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 minimally invasive 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 coaqulating 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, Coaqulating, 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 benion prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer.
1064nm 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.
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 including: Benign and malignant neoplasm; Angiodysplasia; Polyps; Ulcer; Colitis; Hemorrhoids.
General Surgery: 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.
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; intrauterine 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; Meninqioma; Hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.
Oculastics: Incision, Excision, Vaporization and/or coaqulation 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 intraarticular 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 vascularitiesof the bladder wall; prostatectomy.
Product codes
GEX
Device Description
The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems:
- The Optical and Laser resonator System .
- The Electronics and Electrical System .
- . Operator Interface
- A variety of Delivery Devices and Accessories .
- A Cooling Sub-system .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands, gastrointestinal tract, Esophageal, Cervical, vulvar, vaginal, Uterine, Head and Neck/Otorhinolaryngology (ENT), retina, Spinal, lung, Bladder, Urethral & Ureteral, external genitalia, Urethral & penile, prostate, lacrimal system, eyelids, orbital, intraarticular, pulmonary airway, internal organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Laserscope Lyra Surgical Laser System & Accessories, Laserscope Lyra G™ Surgical Laser System & Accessories, 800 Series Surgical Laser System, Modified Coherent VersaPulse Select Single Wavelength . (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories, Laserscope Microbeam IV Micromanipulator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
KO62719
510(k) Summary Statement For the GreenLight HPSTM Surgical Laser System & Accessories
General Information
- A. Trade Name GreenLight HPS™ Series Surgical Laser System & Accessories
- B. Common Name Laser Instrument, Surgical, Powered
- ് Establishment Registration Number
2937094
- D. Manufacturer's Identification
Laserscope 3070 Orchard Drive San Jose, CA 95134-2011 (800) 243-9384-ext. 6795 (408) 943-9630 FAX
Official Correspondent Paul Hardiman Director, Regulatory Affairs
-
E. Device Classification
The GreenLight HPS™ Series Surgical Laser System & Accessories has been specifically classified as a Class II medical device by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels. -
F. Performance Standards
The GreenLight HPS™ Series Surgical Laser System & Accessories conforms with: Federal Regulations; the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems; and, International Harmonized Standards. -
G. Predicate Devices:
- Laserscope Lyra Surgical Laser System & Accessories .
- Laserscope Lyra G™ Surgical Laser System & Accessories ◆
- 800 Series Surgical Laser System
GreenLight HPS™ Surgical Laser System & Accessories Laserscope 510(k) Submission
1
- 800 Series Surgical Laser System & Accessories .
- Modified Coherent VersaPulse Select Single Wavelength . (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices with Accessories
- Laserscope Microbeam IV Micromanipulator .
- H. Product Description:
The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems:
- The Optical and Laser resonator System .
- The Electronics and Electrical System .
- . Operator Interface
- A variety of Delivery Devices and Accessories .
- A Cooling Sub-system .
- I. Indications For Use:
The GreenLight HPS™ Surgical Laser System and Accessories is 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 minimally invasive 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 coaqulating tissue associated with treatments of conditions such as: Endometriosis; Cervical, vulvar, and vaginal intraepitheal neoplasia; Condyloma Acuminata; Uterine Septum; Intrauterine adhesions; Submucosal fibroids.
2
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, Coaqulating, 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 benion prostate hyperplasia/hypoplasia (BPH). The device is not intended to treat prostate cancer.
1064nm 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.
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 including: Benign and malignant neoplasm; Angiodysplasia; Polyps; Ulcer; Colitis; Hemorrhoids.
3
Ko62719
General Surgery: 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.
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; intrauterine 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; Meninqioma; Hemagioblastoma; AVMs; Glioma; Glioblastoma; Astrocytoma; Oligodendroglioma.
Oculoplastics: Incision, Excision, Vaporization and/or coaqulation 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 intraarticular 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,
4
K062719
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 vascularitiesof the bladder wall; prostatectomy.
- J. Rationale for Substantial Equivalence
Laserscope's GreenLight HPS™ Series Surgical Laser System & Accessories share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to the: Laserscope's Lyra Surgical Laser System & Accessories, Lyra G™ Surgical Laser Systems & Accessories; the 800 Series Surgical Laser Systems and Accessories; the Modified Coherent VersaPulse Select Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices and Accessories; and, the Laserscope Microbeam IV Micromanipulator. Details are provided in the Substantial Equivalence Section of this submission.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a bird-like form, with flowing lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 1 2006
Laserscope, LLC % Mr. Paul H. Hardiman Director, Regulatory Affairs 3070 Orchard Drive San Jose, California 95134-2011
Re: K062719
Trade/Device Name: GreenLight HPS™ SURGICAL LASER SYSTEM & Accessories Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 6, 2006 Received: November 7, 2006
Dear Mr. Hardiman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
6
Page 2 -- Mr. Paul H. Hardiman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely your lark N
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE STATEMENT Page 1 of 4
510(k) Number:
062719
Device Name:
GreenLight HPSTM SURGICAL LASER SYSTEM & Accessories
Indications for Use
The GreenLight HPS M 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ota
Prescription Use: X
(per 21 CFR 801.109)
Over -The-Counter-Use and Neurological Devices
510(k) Number LOC2715
00001
8
INDICATIONS FOR USE STATEMENT Page 2 of 4
510(k) Number:
0627/9
Device Name:
GreenLight HPS™ SURGICAL LASER SYSTEM & Accessories
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, 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 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 in the gastrointestinal tract: Esophageal
neoplastic obstructions including Squamous cell carcinoma and Adenocarcinoma;
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use.
(per 21 CFR 801.109)
or
Over -The-Counter-Use
9
INDICATIONS FOR USE STATEMENT Page 3 of 4
510(k) Number:
062719
Device Name:
GreenLight HPS™ SURGICAL LASER SYSTEM & Accessories
Gastroenterology (contd.): Gastrointestinal hemostasis including: Varices, Espohagitis. Esophageal Ulcer, Mallory-Weiss tear, Gastric Ulcer, Angiodysplasia, Stomal ulcers, nonbleeding 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, 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 surqical and arthroscopic applications.
Plastic Surgery: Cutting (incision/excision), coagulating, and vaporizing of soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use-
(per 21 CFR 801.109)
or
Over -The-Counter-Use
00003
10
INDICATIONS FOR USE STATEMENT Page 4 of 4
510(k) Number:
062719
Device Name:
GreenLight HPS™ SURGICAL LASER SYSTEM & Accessories
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, 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use.
(per 21 CFR 801.109)
or
Over -The-Counter-Use