Search Results
Found 3 results
510(k) Data Aggregation
(83 days)
The Holmium laser system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and haemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynecology, ENT and General Surgery.
The Potent HP Series is a family of pulsed solid-state Holmium:YAG laser systems that deliver energy at a wavelength of 2100 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a flashlamp-pumped Ho:YAG laser medium, and the laser energy is transmitted to the target site via SMA905-compatible optical fibers. All models in the series share the same fundamental design and operational principles, differing in maximum average power output and frequency. The system includes a touchscreen interface, dual-pedal footswitch, fiber auto-recognition, integrated liquid cooling, and multiple built-in safety features such as an emergency stop, door interlock, and real-time monitoring of laser output.
N/A
Ask a specific question about this device
(83 days)
The Thulium Fiber Laser System is intended for incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft tissue, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Urology
- Ablation of Benign Prostatic Hyperplasia (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
- 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
- Angiodysplasia
- Polyps
- Colorectal cancer
- Biopsy
- Telangiectasias
- Gall Bladder calculi
- Telangiectasias of the osler-weber-Renu disease
- Biliary/Bile duct calculi vascular Malformation
- Ulcers
- Gastritis
- Gastric ulcers
- Esophagitis
- Duodenal ulcers
- Esophageal ulcers
- Non Bleeding ulcers
- Varices
- Pancreatitis
- Colitis
- Haemorrhoids
- Mallory-weiss tear
- Cholecystectomy
- Gastric Erosions
- Benign and Malignant Neoplasm
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
The Thulium Fiber Laser System is a pulsed solid-state Thulium fiber laser system that delivers energy at a wavelength of 1940 nm through optical fibers for soft tissue surgery and stone fragmentation. The system utilizes a diode-pumped Thulium-doped fiber laser medium, and the laser energy is transmitted to the target site via standard optical fibers. The system is designed for surgical applications requiring precise tissue ablation, coagulation, and stone fragmentation.
The system includes an intuitive touchscreen interface, dual-pedal foot switch, integrated cooling system, and comprehensive safety features including emergency stop, door interlock, key switch, and real-time monitoring of laser parameters.
N/A
Ask a specific question about this device
(62 days)
PT-OF-X-S Series Laser Fiber (Models PT-OF-A-S, PT-OF-B-S, PT-OF-C-S, PT-OF-D-S, PT-OF-E-S, PT-OF-F-S) is indicated for to deliver laser energy from a source to the target tissue in laser surgery applications, when used with any cleared/certified laser with wavelengths 1940nm - 2100nm equipped with SMA 905 standard connector.
The PT-OF-X-S Series Laser Fiber is a reusable (up to 10 uses) optical fiber delivery system designed to transmit laser energy from compatible laser sources to surgical treatment sites. The device utilizes high-purity quartz glass core technology with total internal reflection principles to deliver precise laser energy for various surgical applications.
The system features an SMA-905 standard connector for universal compatibility with cleared laser systems operating at wavelengths between 1940nm and 2100nm. Each fiber incorporates an integrated RFID module for usage tracking and cycle management, ensuring safe reuse within validated parameters.
The device is supplied non-sterile and requires sterilization prior to use. It is designed for professional use in healthcare facilities by physicians familiar with laser surgical procedures.
N/A
Ask a specific question about this device
Page 1 of 1