# K210142: Fiber Dust

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Mar 11, 2021 after 51 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
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories), Olympus Surgical Technologies America (2019). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K252787: Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) (2025), 0 descendants of its own
- K242987: Thulium Fiber Laser (FiberLAZE+, FiberLAZE) (2024), 0 descendants of its own
- K242293: Medical Thulium Fiber Laser Systems (UroFiber 60Q) (2024), 0 descendants of its own
- K220426: Fiber Dust PRO (2022), 0 descendants of its own

## 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 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/K210142
Methodology: https://510kreport.com/methodology