510(k) Report

510(k) · Cleared

Cleared

800 Series Surgical Laser System and Acccessories

K970948510(k) TraditionalCleared May 21, 199768-day reviewClass II21 CFR 878.4810

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 May 21, 1997 after a 68-day review. The FDA summary names no predicate by number.

Decided
May 21, 1997
Review
68 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K970948Source: FDA 510(k) database · 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.

Planning a device in GEX? 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
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

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 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…

Read the full statement (700 words)

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).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K970948: 800 Series Surgical Laser System and Acccessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970948

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026