Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Litho laser system and its fiber optic delivery 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 medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Gynaecology, ENT and General Surgery. Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: • Urethral Strictures • Bladder Neck Incisions (BNI) • Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors • Ablation of Benign Prostatic Hypertrophy (BPH) • Transurethral incision of the prostate (TUIP) • Holmium Laser Resection of the Prostate (HoLRP) • Holmium Laser Enucleation of the Prostate (HoLEP) • Holmium laser Ablation of the Prostate (HoLAP) • Condylomas • Lesions of external genitalia 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 kidney 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-Rendu disease • Vascular Malformation • Gastritis • Esophagitis • Esophageal ulcers • Varices • Colitis • Mallory-Weiss tear • Gastric Erosions Arthroscopy Arthroscopy/Orthopaedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: • Ligament and tendon Release • Contouring and sculpting of articular surfaces • Capsulectomy in the Knee • Chondreplasty in the Knee • Debridement of inflamed synovial tissue • Chondromalacia Ablation • Chondromalacia and tears • Plica Removal • Meniscectomy • Loose Body Debridement • Lateral retinacular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including: • Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty • Percutaneous Cervical Disc Decompression/Discectomy • Percutaneous Thoracic Disc Decompression/Discectomy Gynaecology Open and laparoscopic gynaecological surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) of soft tissue. ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and h
Litho laser system and its fiber optic delivery 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, Gynaecology, ENT and General Surgery.
Litho family includes surgical laser devices that are used by health care professionals in professional healthcare environments. Litho family includes the following models: Litho 60, Litho 100 and Litho 150. They differ only for the maximum power: 60, 105 and 152, respectively. Litho devices are connected to optical fibers accessories (separately FDA cleared: K131473, K160513, K200234). The device is equipped with a graphical user interface through which the user can set energy, frequency and pulse duration level. Different pre-sets are available among which the so called 'special effects': Virtual Basket and Magneto. Virtual basket and Magneto are optional configurations. Virtual basket consists of two sub-pulses separated by a certain delay. The first pulse generates a cavitation bubble and the second one is emitted when the first bubble reaches its maximum expansion. This allows the stone to be 'caught' to be fragmentated. The set energy is the sum of the energy of the two sub-pulses. While Magneto consists of a pulse with a duration higher than standard one (2000 µs vs 1100 µs). Devices with Magneto configuration installed are characterized by black covers and Magneto logos. The device can be divided into four main sections: Power electronics, Control electronics, Cooling system, Optical bench.
Summary parsed at:2026-06-01 05:29:17 UTC
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