# K242987: Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

- Pathway: 510(k) (Traditional)
- Applicant: Allengers Global Healthcare Private Limited
- Decided: Dec 17, 2024 after 82 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 6.

## Indications for use
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

Source page: https://510kreport.com/device/K242987
Methodology: https://510kreport.com/methodology