# K970948: 800 Series  Surgical Laser System and Acccessories

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: May 21, 1997 after 68 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The 800 Series Surgical Laser System and Accessories is intended to be used for the following indications: ... : KTP/532 nm Applications: Dermatology - indications inciude photocoagulation, hemostasis, color lightening, blanching flattening and reduction of lesion size for the following categories of lesions: vascular lesions including angiomas, hemangiomas, telangiectasia; benign pigmented lesions including nevi, lentigines, chloasma, cafe-au-lait, tattoos; cutaneous lesions including verrucae, skin tags, keratoses and plaques. Gasteroenterology - indications for hemostasis in the gastrointestinal tract including varices, esophagitls, esophageal uicer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal uicers, non-bleeding uicers and gastric erosions. Indications for tissue abiation in the gastrointestinal tract including benign and malignant neoplasms, angiodysplasia, polyps, ulcers, colitis and hemormhoids. indications for esophageal neoplastic obstructions including squamous cell carcinoma and adenocarcinoma. General Surgery - indications include vaporization, coagulation, incision, excision, debulking and ablation of soft tissue in endoscopic or open procedures. Gynecology - indications include vaporization, incision and coagulation of tissue associated with treatments for conditions such as endometriosis; cervical, vulvar and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adheslons and submucosal fibroids. Head and Neck/Otorhinolaryngology (ENT) - indications include tissue incision, excision ablation and vessel hemostasis. Neurosurgery - indications include incision, excision, coagulation and vapa'lzatlon of neurosurgical tumors of the firm, textured type. Ophthalmology - indications include post-vitrectomy endophotocoaguiation of the retina. Plastic Surgery - indications include vaporization, coagulation, incision, exdsion debu'king and ablation of scft tissue in endoscopic and open procsdures. Spinal Surgery - indications include parcutaneous lumbar discectomy. Thoracic Surgery - indications include vaporization, coagulation, incision, excision, debulking and abiation of soft tissue, including lung tissue in thoracoscopic or open procedures. Urology - indications include cutting, coagulation or vaporization of soft tissue dugi urologic procedures. Nd:YAG/1064 Applications: Dermatology - indications include photocoagulation of pigmented vascular lesions to reduce lesion;size; for patients with lesions that would potentially benefit from aggressive treatment; and for patients with lesions that have not responded to other laser treatments. Gasteroenterology - indications for hemostasis in the gastrointestinal tract, including varices, esophagitis, esophageal uicer, Mallory-Weiss tear, gastric uicer, angiodysplasia, stomal ulcers, non-bleeding ulcers and gastric erosions. Indications for tissue ablation in the gastrointestinal tract including benign and malignant neoplasms, angiodysplasia, polyps, uicers, colitis and hemorrhoids. Indications for esophageal neog!aslic obstructions including squamous cell carcinoma and adenocarcinoma. General Surgery - indications include cutting, ablation and/or hemostasis of soft tissue in endoscopic/laparoscopic and open general surgical applications, including cholecystectomy, appendectomy, vagotomy and pyloromyotomy. Soft tissue general surgical indications include skin incision, tissue dissection, excision of extemal tumors and leslons, tissue ablation, vessel coagulation and complete or partial resection of intemal organs, tumors and lesions. Gynecology - indications include 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 and uterine septum. Head and Neck/Otorhinolaryngology (ENT) - indications include tissue incision, excision, ablation and vessel hemostasis. Hemostasis During Surgery - indications include adjunctive coagulation and hemostasis (bleeding control) during surgery in endoscopic and open procedures. Neurosurgery - indications include hemostasis for pituitary tumor, meningioma, hemoglioblastoma, AVMS, glioma, glioblastoma, astrocytoma and ofigodendroglioma. Oculoplastics - indications include incision, excision, vaporization and/or coagulation of tissue in oculoplastic procedures such as operations on the lacrimal system, operations on the eyelids, removal or biopsy of orbital tumors, enucleation of eyeball, exenteration of orbital contents. Orthopedics - indications include cutting, ablation and/or hemaostasis of intra-articular tissue in orthopedic surgical and arthroscopic applications. Plastic Surgery - indications include cutting, incision, excision. coagulation and vaporizationof soft iissue. Pulmonary Surgery - indications include palliative procedures for benign and maiignant pulmonary airway obstructions, including squamous cell carcinoma, adenocarcinoma, carcinoid, oenign turnors, granulomas, trachea! stenosis and benign strictures. Thoracic Surgery - indications include cutting, incision, excision, coagulation and vaporization of soft tissue. Thoracic applications, including isolation of vesseis for endarterectomy and/or bypass grafts, wedge resections, thoracotomy, formation of pacemaker pockets, vaporization, coagulation, incision, excision debu and apigtion of lung tissue (thoracoscopy). Urology - indications include superficial urinary bladder tumors, invasive bladder carcinoma, urethreal strictures, bladder neck contracture, diverticulum and lesions of the extemal genitalia (including condyloma acuminata).

Source page: https://510kreport.com/device/K970948
Methodology: https://510kreport.com/methodology