Fiber Dust

Quanta System Spa

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

4

Device details

FDA 510(k) registration fields

K number
K210142
Device name
Fiber Dust
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

0

No predicate K numbers were extracted

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Cited as predicate

4

4 submissions cite K210142 as a predicate