Manufacturer
Quanta System SpaFiber Dust PRO
Country / Region:Italy (IT)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K220426
- Device name
- Fiber Dust PRO
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-02-14
- Decision date
- 2022-03-16
- Submission type
- Special
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
Fiber Dust PRO 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 PRO 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.
Device Description
Fiber Dust PRO is a laser system that emits a wavelength of 1940 nm with a laser output power up to 60W. Laser radiation is delivered to the patient via a quartz optical fiber having a diameter up to 1000 μm. The main subsystems of the device are the laser, the power electronics, the optical delivery system, the control electronics, and the cooling system. Software controls the device functions and allows the user to select device settings. Laser emission is triggered by a footswitch.
Summary parsed at:2026-06-01 05:39:49 UTC
Predicate devices
1Fiber Dust
K220426 references 1 predicate/reference device
Cited as predicate
1MultiPulse TFL
1 submission cite K220426 as a predicate
