# K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser

- Pathway: 510(k) (Traditional)
- Applicant: Instruments For Medicine and Diagnostics
- Decided: Sep 1, 1998 after 90 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.
763 later devices descend from it; 7 cite it directly.
0 of 764 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) Coherent VersaPulse: named in the summary without a submission number
- (no number) Thermolase Softlight Laser: named in the summary without a submission number
- (no number) Laserscope Orion Series Laser System: named in the summary without a submission number
- (no number) Cynosure PhotoGenica LPIR Laser: named in the summary without a submission number

## Most influential descendants
- K991234: The Acme Medical Aesthetic ND:Yag Laser (1999), 755 descendants of its own
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models (2002), 739 descendants of its own
- K993671: Candela Sclero Long Pulse Dye Laser (2000), 700 descendants of its own
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam) (2002), 699 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own

## Indications for use
532nm Wavelength: General Surgery: Coagulation, hemostasis, vaporization, excision, and incision of tissue. Photocoagulation of Vessels/Veins up to 1.5 mm Endoscopic & Laparoscopic: Excising, Coagulation or Vaporization of tissue during Endoscopic or Laparoscopic procedures, Cholecystectomy and Appendectomy. Gynecology: Ablation or lysis of intra-abdominal tissues via laparotomy or laparoscope. Ablation of endometrial implants, lysis of adhesions, ablation of the uterosacral ligaments, cutting/coagulating, treatment of uterine polyps and fibroids, salpingo-ophorolysis, and transection of uterine septa. Laryngology: Photocoagulation or Vaporization of soft or fibrous tissue such as; hereditary hemorrhagic telangiectasia (vascular lesions), pigmented structures that are highly vascular, and tonsillectomy. Otology: For; stapedotomy, stapedectomy, tympanoplasty with fascia graft, myringotomies, control of bleeding, removal of osseous disease of the external canal, removal of acoustic neuromas, lysis of adhesions and soft tissue adhesion, in both micro- and macro- otologic procedures. Rhinology: For; control of epistaxis, turbinate reduction (excludes bone), treatment of endonasal polyps, hereditary hemorrhagic telangiectasia, synechia, hemangiomas, telangiectasia, vaporize of maxillary sinus cysts and polyps, treatment of papillomas and granulomas, endonasal dacryocystorhinostomy, treatment of lesions within the nose and sinus, creation of nasoantral window and coagulation of vessels or veins up to 1.5 mm in diameter. Urology: Coagulation of veins or vessels up to 1.5 mm in diameter, management of condyloma acuminata, carcinoma in situ, small papillary bladder tumors, port wine stains, hemangioma of the external genitalia or bladder and urethral recanalization. Neurosurgery: For; dorsal root entry zone lesions, spinal intramedullary tumor, medulloblastomas, acoustic neuromas, intracranial meningiomas, ventricular ependymomas, choroid plexus, carcinomas, hemangioblastomas, ependymoma extending into the brain stem, and intra- / extra- axial spinal cord tumors. Ophthalmology: For; posterior and anterior treatment procedures including; diabetic retinopathy, retinal detachments, ablate tissues of the iris or trabeculum, peripheral iridectomy and iridotomy, trabeculoplasty, and senile macular degeneration. Other conditions of the retina in which the laser is deemed useful involving endophotocoagulation. Extraorbital procedures such as; coagulation of vessels or veins up to 1.5 mm in diameter, extra orbital pigmented or venous lesions; port wine hemangiomas or telangiectasia. Treatment for chronic dacryocystitis. Dermatology: For; treating vascular lesions, dermatologic lesions, and/or cutaneous lesions such as; facial or extremities telangiectasias, venous anomalies, leg veins up to 1.5 mm in diameter, and port wine stains. 1064nm Wavelength: General Surgery: For; incision or excision of all soft body tissues including; skin, subcutaneous and breast tissue, striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymphatic tissue, internal organs and glands of the gastrointestinal, genitourinary, pulmonary, endocrine and exocrine systems, as well as cancers of theses systems. Treatment of larger and deeper vessels/veins up to 3.0 mm in diameter, 4.0 to 7.0 mm in depth. ENT, Head & Neck: For; incision or excision of all soft body tissues including; skin, subcutaneous tissue, striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymphatic tissue, organs and glands of the ENT system and access via endoscope, microscope or direct visualization. Gastroenterology: For; esophageal neoplastic obstructions such as; squamous cell carcinoma, and adenocarcinoma, upper and lower GI bleeding such as; varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, stomach ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions and hereditary hemorrhagic telangiectasia. Papilliation of unresectable mucosal-based cancers, coagulation of arteriovenous malformations, ablation of; adenomatous polyps, benign and malignant neoplasm, angiodysplasia, polyps, ulcers, colitis and hemorrhoids. Recanalization of obstructing lesions throughout the gastrointestinal tract, and endoscopic treatment of early oesophageal or gastric cancer. Gynecology: For; endometrial ablation, treatment of menorrhagia, treatment of endometrotic implants, lysis of adhesions, treatment of cervical, vaginal, or vulvar dysplasia, and treatment of cervical, vaginal, or vulvar condyloma. Neurology: For; treatment of arterio-venous malformations, and vascular intracranial tumors like meningiomas and metastatic spinal tumors. Pulmonary: For; treatment of benign and malignant tracheobronchial lesions in the pulmonary airway including; squamous cell carcinoma, papillomas, adenocarcinoma, granulomas, and tracheal stenosis. Urology: Treatment of superficial and invasive bladder carcinoma, urethral and ureteral strictures, benign or malignant lesions of the external genitalia, urethra and anus (condyloma acuminata), bladder neck contracture, and diverticulum. Dermatology: Photocoagulation of vascular lesions for the reduction of lesion size. Treatment of vascular lesions such as; port wine stains (PWS), hemangiomas, angiomas, and venous anomilies. Incision/Excision of soft body tissues. Otolaryngology: Bronchoscopy procedures such as; photocoagulation of endobronchial tumors.

Source page: https://510kreport.com/device/K981952
Methodology: https://510kreport.com/methodology