# K973828: Prima KTP Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Jan 5, 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.
76 later devices descend from it; 1 cites it directly.
0 of 77 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’s Aura KTP laser system: named in the summary without a submission number

## Most influential descendants
- K041930: Varilite Laser System (2004), 75 descendants of its own
- K091534: Lightlas Model 532 (2009), 72 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (2010), 46 descendants of its own
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (2011), 26 descendants of its own

## Indications for use
The Prima KTP lasers are intended for the surgical treatment (i.e., incision, excision, abfation, coagulation, vaporization, debulking or hemostasis) of soft tissue in all surgical applications. This includes: Head and Neck (ENT), General Surgery, Plastic Surgery, Thoracic Surgery and Urology. Dermatology: Photocoagulation of cutaneous lesions, including the following general categories of lesions: Vascular lesions; Angiomas, hemangiomas, telangiectasia. Benign pigmented lesions; Nevi, Lentigines, chloasma, café-au-lait, Tattoos. Other Cutaneous Lesions, Verrucae, Skin Tags, Keratoses, Plaques. Cutaneous Lesion Treatment Goals Include; Hemostasis, Color Lightening, Blanching, Flattening, Reduction of Lesion Size. Gastroenterology: Ablation of esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma. Ablation and excision of obstructive colorectal carcinoma. Hemorrhoidectomy. Ablation of villous adenoma in non-operative patients. Ablation of familial polyposis of the colon. Excision of gastric cancer. Ablation of sessile polyps of the colon. Gynecology: Vaporizing, incising or coagulating tissue associated with treatments for conditions such as; Endometriosis, Cervical, vulvar and vaginal intraepithael neoplasia. Condyloma acuminata. Interuterine septum. Intrauterine adhesions. Submucosal fibroids. Neurosurgery: Vaporizing, coagulating, incising, excising, debulking, and ablating neurological tissue in both open and endoscopic intracranial procedures such as: Third ventriculostomy, transseptal fenestration, intraventricular cysts fenestration, ventriculocystostomy, tumor biopsy and excision, removal of proximal shunts occluded by choriod plexus. Ophthalmology: Post-vitrectomy endophotocoagulation of the retina. Spinal Surgery: Percutaneous lumbar diskectomy.

Source page: https://510kreport.com/device/K973828
Methodology: https://510kreport.com/methodology