Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Leonardo® Duster 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/ureteral structures • 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 hemostasis) 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 Gynecology Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
The Leonardo® Duster 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/ureteral structures, 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 hemostasis) 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. Gynecology: Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.
All variants of the laser family LEONARDO® Duster are laser systems with
Summary parsed at:2026-06-01 05:22:27 UTC
No later 510(k)s cite this device yet
Other submissions will appear here when they list K250504 as a predicate
