Manufacturer
Quanta System SpaFiber Dust
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Predicate devices
0
Cited in this 510(k)
Device details
FDA 510(k) registration fields
- K number
- K210142
- Device name
- Fiber Dust
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-01-19
- Decision date
- 2021-03-11
- Submission type
- Traditional
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingOtherOtherOther
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
Fiber Dust 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 • 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 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.
Intended Use
Fiber Dust 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.
Summary parsed at:2026-06-01 05:42:39 UTC
Predicate devices
0No predicate K numbers were extracted
The Summary PDF may not be parsed yet, or this submission may not cite predicate devices
Cited as predicate
4Fiber Dust PRO
Medical Thulium Fiber Laser Systems (UroFiber 60Q)
Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
4 submissions cite K210142 as a predicate
