510(k) · Cleared
ClearedThulium Fiber Laser (FiberLAZE+, FiberLAZE)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allengers Global Healthcare Private Limited · GEX Powered Laser Surgical Instrument
Cleared on Dec 17, 2024 as substantially equivalent to K210142 (Quanta System Spa, 2021) after an 82-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Dec 17, 2024
- Review
- 82 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K210142 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backK210142 Fiber DustQuanta System Spa · 2021
- This deviceK242987 Thulium Fiber Laser (FiberLAZE+, FiberLAZE)Allengers Global Healthcare Private Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K210142 | Fiber Dust | Quanta System Spa | 2021 | — |
| 0 (this device) | K242987 | Thulium Fiber Laser (FiberLAZE+, FiberLAZE) | Allengers Global Healthcare Private Limited | 2024 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210142 | Fiber DustSummary page 6…21 CFR 878.4810 Product Code GEX Panel General and Plastic Surgery Predicate Device Fiber Dust (K210142) -Quanta system SpA Reference Device Soltive Laser System(K183647)-Olympus Surgical Technologies… | 2021 |
| † | K183647 | SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K210142.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Thulium Fiber Laser is intended for incision, excision, resection, ablation, vaporization, coagulation, and haemostasis of soft tissue 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…
Read the full statement (259 words)
Thulium Fiber Laser is intended for incision, excision, resection, ablation, vaporization, coagulation,
and haemostasis of soft tissue 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/K242987 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242987: Thulium Fiber Laser (FiberLAZE+, FiberLAZE).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242987
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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