# K142286: NS3000 Holmium Laser System

- Pathway: 510(k) (Special)
- Applicant: New Star Lasers, Inc.
- Decided: Oct 31, 2014 after 74 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: 2 generations back to K033437 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132607: NS 2500 Holmium Laser System, New Star Lasers, Inc. (2014) Summary page 4.
- K033437: Sphinx Laser Systems, Allmed Systems, Inc. (2004) Summary page 6.

## Recalls of this device
- May 13, 2015 · Class II · Z-1918-2015: During internal testing a situation was discovered where when changing the settings, a new setting could not be accepted and potentially result in a discrepancy in the energy delivered (higher or lowe

## Indications for use
The NS3000 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 (BNI), ablation and resection of bladder tumors, uretheral tumors and ureteral tumors, condylomas, 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/K142286
Methodology: https://510kreport.com/methodology