# K132607: NS 2500 Holmium Laser System

- Pathway: 510(k) (Traditional)
- Applicant: New Star Lasers, Inc.
- Decided: Mar 21, 2014 after 213 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 K033437 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033437: Sphinx Laser Systems, Allmed Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K142286: NS3000 Holmium Laser System (2014), 0 descendants of its own

## Indications for use
The NS250O laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy. and General Surgery Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: urethral strictures, bladder neck incisions (B3NI), ablation and resection of bladder tumors, uretheral tumors and ureteral tumors, condylonias, and lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi, endoscopic fragmentation of kidney calculi, and treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: skin incision, excision of external and internal lesions, complete or partial resection of internal organs, tumors and lesions, and biopsy

Source page: https://510kreport.com/device/K132607
Methodology: https://510kreport.com/methodology