# K232568: IPG Medical Family of Thulium  Fiber Lasers, Surgical Fibers, and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Ipg Medical Corporation
- Decided: Mar 21, 2024 after 210 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K936109 (1994). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211401: SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories), Gyrus Acmi, Inc. (2021) Summary page 5.
- (no number) vela XL Laser System: named in the summary without a submission number

## Most influential descendants
- K251100: Ipgtfl-02 (2025), 0 descendants of its own

## Recalls of this device
- May 5, 2026 · Class II · Z-2554-2026: Software anomaly that causes a false display of error code 5018.

## Indications for use
The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indication: 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 dihydrate stones ● Endoscopic fragmentation of 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 hemostasis) 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 ● Hemorrhoids ● 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/K232568
Methodology: https://510kreport.com/methodology