# K023257: Endoscopic Laser Delivery System-Lasertx

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Mar 28, 2003 after 179 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Endoscopic Delivery System -LaserTx with diffuser-tip fiberoptic delivery catheter is indicated for general tissue coagulation & ablation during general surgery, general urological, general gynecological and general gastroenterological procedures, and Endoscopic laser coagulation of tumors, fibroids and other soft tissue. The Endoscopic Laser Delivery System -LaserTx with bare-tip fiberoptic is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures.

Source page: https://510kreport.com/device/K023257
Methodology: https://510kreport.com/methodology