# K252787: Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.
- Decided: Nov 24, 2025 after 83 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
The Thulium Fiber Laser System is intended for incision, excision, resection, ablation, coagulation, hemostasis and vaporization of soft tissue, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology • Ablation of Benign Prostatic Hyperplasia (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 • 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 ofthe 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/K252787
Methodology: https://510kreport.com/methodology