# K211517: Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Convergent Laser Technologies
- Decided: Nov 9, 2021 after 176 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
Longest line of descent: 9 generations back to K936109 (1994). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories), Olympus Surgical Technologies America (2019) Summary page 5.

## Indications for use
The Optica XT Thulium Fiber Laser and Accessories is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology * Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH] * Laser Resection of the Prostrate (LRP) * Laser Enucleation of the Prostate (LEP) * Laser Ablation of the Prostate (LAP) * Transurethral Incision of the Prostate (TUIP) » Condylomas * Urethral strictures * Lesions of external genitalia * Bladder neck incisions (BNI) * Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors * Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi * Treatment of distal impacted fragments remaining in the ureters following lithotripsy Lithotripsy and Percutaneous Urinary Lithotripsy Indications * Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones * Endoscopic fragmentation of renal calculi » Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: » Appendectomy * Polyps * Biopsy * Gall Bladder calculi * Biliary/Bile duct calculi * Ulcers * Gastric ulcers * Duodenal ulcers * Non Bleeding Ulcers * Pancreatitis » Haemorrhoids * Cholecystectomy * Benign and Malignant Neoplasm *» Angiodysplasia » Colorectal cancer * Telangiectasias » Telangiectasias of the Osler-Weber-Renu disease * Vascular Malformation * Gastritis * Esophagitis * Esophageal ulcers * Varices * Colitis » Mallory-Weiss tear * Gastric Erosions Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

Source page: https://510kreport.com/device/K211517
Methodology: https://510kreport.com/methodology