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

Convergent Laser Technologies

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K211517
Device name
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
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-05-17
Decision date
2021-11-09
Submission type
Traditional
Technology type
Thulium fiber(AI inferred)
Clinical applications
Surgical cuttingOtherOtherOther
Primary application
Surgical cutting
Classification source
AI classified

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 Prostate (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.

Intended 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.

Device Description

The Optica XT Thulium Fiber Laser is a thulium fiber laser emitting laser radiation at 1940 nm with a laser output power of 60 Watts. Laser activation is by footswitch. The overall weight of the laser is 95 lbs., and the size is 20" W x 24" L x 16" H. The Optica XT Thulium Fiber Laser has an electrical requirement of 100-240 VAC, 50/60 Hz. Laser energy is delivered to the target site using a fiber optic delivery system with diameters from 150-1000 micron.

Summary parsed at:2026-06-01 05:43:10 UTC

Predicate devices

1

K211517 references 1 predicate/reference device

Cited as predicate

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