Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The IPGTFL-02 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 with integrated detection of calculi and mucosal tissue by StoneSense module that reduces exposure of mucosal tissue to laser energy and reduces resulting damage to mucosal tissue • 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 dihydrate 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 hemostasis) 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 • Hemorrhoids • 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 IPGTFL-02 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 with integrated detection of calculi and mucosal tissue by StoneSense module that reduces exposure of mucosal tissue to laser energy and reduces resulting damage to mucosal tissue, 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 dihydrate 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 hemostasis) 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, Hemorrhoids, 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.
IPGTFL-02 is a desktop, portable thulium laser source and controller used with specific surgical fibers (single-use & reusable) for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope. The laser system generates non-ionizing radiation which is transferred to the relevant anatomical treatment site through surgical fibers that serve as the delivery vehicle from the laser energy generator to the treatment site. The laser system includes a universal, three-pedal footswitch that can operate in wired and wireless mode for hands-free control. The system can utilize a customer-supplied, medical grade external surgical monitor to display endoscope video as well as the device's user interface. The laser system's front panel includes a surgical fiber connection port and a touchscreen with a user interface. The rear panel includes electrical and interface cable ports. The laser system may be placed on an optional, mobile cart. The system can utilize an auxiliary video monitor to display operating parameters. The laser system can operate at a maximum power output of 60 watts in CW, regular and advanced Pulsed modes with a maximum frequency output of 2400 Hz and a maximum pulse energy of 6 Joules. The laser system must be operated with the IPG Medical Surgical Fibers. The surgical fibers are flexible optical fibers that deliver the laser energy to the target tissue. The surgical fibers are the only patient-contacting components of the IPGTFL-02. The purpose of this 510(k) is to add an optional module called StoneSense for lithotripsy procedures. During these procedures it is possible that the fiber tip loses contact or quasi-contact with the stone which is undesirable. The module is designed to detect if the object in contact or quasi-contact with the distal fiber tip is 'Stone' or 'Not Stone'. If Stone is not detected, the system will not allow emission of the laser. The addition of Stone sense will add an indication for the device. Also, three advanced power modes have been added: Fragmentation Pulse - Special pulse shape, optimized for stone ablation into large fragments. Minimal Carbonization Pulse - Special pulse shape for soft tissues vaporization, incision and excision with minimization of tissue carbonization. Enucleation Pulse - Special pulse shape, developed for enucleation procedure to maximize thermo-mechanical separation of adenomic tissue and capsule with simultaneous strong hemost
Summary parsed at:2026-06-01 05:22:56 UTC
IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
K251100 references 1 predicate/reference device
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