510(k) · Cleared
ClearedFiber Dust
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta System Spa · GEX Powered Laser Surgical Instrument
Cleared on Mar 11, 2021 after a 51-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Mar 11, 2021
- Review
- 51 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 4 citing it directly.
- This deviceK210142 Fiber DustQuanta System Spa · 2021
- Descendant · cites it directly · 0 of its ownK252787 Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK242987 Thulium Fiber Laser (FiberLAZE+, FiberLAZE)Allengers Global Healthcare Private Limited · 2024
- Descendant · cites it directly · 0 of its ownK242293 Medical Thulium Fiber Laser Systems (UroFiber 60Q)Rhein Laser Technologies Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK220426 Fiber Dust PROQuanta System Spa · 2022
Most influential descendants
Showing 4 of 4 · See all- K252787Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. · 2025 · cites it directly0descendants
- K242987Thulium Fiber Laser (FiberLAZE+, FiberLAZE)Allengers Global Healthcare Private Limited · 2024 · cites it directly0descendants
- K242293Medical Thulium Fiber Laser Systems (UroFiber 60Q)Rhein Laser Technologies Co., Ltd. · 2024 · cites it directly0descendants
- K220426Fiber Dust PROQuanta System Spa · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K210142 | Fiber Dust | Quanta System Spa | 2021 | — |
| +1 | K252787 | Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025 | — |
| +1 | K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Allengers Global Healthcare Private Limited | 2024 | — |
| +1 | K242293 | Medical Thulium Fiber Laser Systems (UroFiber 60Q) | Rhein Laser Technologies Co., Ltd. | 2024 | — |
| +1 | K220426 | Fiber Dust PRO | Quanta System Spa | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K183647 | FDA’s K183647 is SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2019 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K252787 (Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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) *…
Read the full statement (264 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210142: Fiber Dust.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210142
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026