510(k) · Cleared

Recalled · Class II · 2015

NS3000 Holmium Laser System

K142286510(k) SpecialCleared Oct 31, 201474-day reviewClass II21 CFR 878.4810Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

New Star Lasers, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Oct 31, 2014 as substantially equivalent to K132607 (New Star Lasers, Inc., 2014) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 2004. It has been recalled once.

Decided: Oct 31, 2014
Review: 74 days
Class: Class II
Product code: GEX
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K033437 (2004). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK033437 Sphinx Laser SystemsAllmed Systems, Inc. · 2004
1 generation backK132607 NS 2500 Holmium Laser SystemNew Star Lasers, Inc. · 2014
This deviceK142286 NS3000 Holmium Laser SystemNew Star Lasers, Inc. · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K033437	Sphinx Laser Systems	Allmed Systems, Inc.	2004	—
−1	K132607	NS 2500 Holmium Laser System	New Star Lasers, Inc.	2014	—
0 (this device)	K142286	NS3000 Holmium Laser System	New Star Lasers, Inc.	2014	—

FIG. 1 — Lineage of K142286, 2004–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K132607	NS 2500 Holmium Laser System Summary page 4 …Class II FDA Panel: General and Plastic Surgery Product Code: GEX III. Predicate NS2500™ Laser System (K132607) IV. Device Description The New Star Model NS3000 is a compact, portable, self-contained system that produces a…	New Star Lasers, Inc.	2014	—
*	K033437	Sphinx Laser Systems Summary page 6 …opsy. VII. Summary of Technological Characteristics Technical K132607 K142286 Characteristics K033437 NS2500 New Star Laser NS3000 New Star Laser (Predicate)…	Allmed Systems, Inc.	2004	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 13, 2015	Class II	Z-1918-2015	Software design (manufacturing process)	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 lower) from the value displayed on the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 10.2 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

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…

Read the full statement (145 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K142286 · printed Nov 5, 2026

Cite this page

510(k) Report. “K142286: NS3000 Holmium Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142286

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026