# K220426: Fiber Dust PRO

- Pathway: 510(k) (Special)
- Applicant: Quanta System Spa
- Decided: Mar 16, 2022 after 30 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K210142 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210142: Fiber Dust, Quanta System Spa (2021) Summary page 5.

## 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 Prostrate (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.

Source page: https://510kreport.com/device/K220426
Methodology: https://510kreport.com/methodology