Manufacturer
Ipg Medical CorporationIPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K232568
- Device name
- IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories
- Company
- Ipg Medical Corporation
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-08-24
- Decision date
- 2024-03-21
- Submission type
- Traditional
- Technology type
- Thulium fiber(AI inferred)
- Clinical applications
- Surgical cuttingOtherVascular treatmentAcne treatment
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indication: 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 dihydrate stones ● Endoscopic fragmentation of 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.
Intended Use
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indication: urology, lithotripsy, gastroenterological surgery and gynecological surgery.
Device Description
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories are portable thulium fiber lasers that generate non-ionizing radiation which is transferred to the relevant anatomical treatment site through surgical fibers. The system includes wireless and wired footswitches for hands-free control, an auxiliary video monitor, a surgical fiber connection port, a touchscreen user interface, and operates on emission wavelengths between 1920 and 1960 nm. It can operate at a maximum power output of 60 watts and a maximum frequency output of 2400 Hz with a maximum pulse energy of 6 Joules. The surgical fibers are flexible optical fibers that deliver the laser energy to the target tissue and are offered in a range of core diameters from 150 microns to 940 microns.
Summary parsed at:2026-06-01 05:26:34 UTC
Predicate devices
1SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
K232568 references 1 predicate/reference device
Cited as predicate
1IPGTFL-02
1 submission cite K232568 as a predicate
