510(k) · Cleared

Cleared

NS 2500 Holmium Laser System

K132607510(k) TraditionalCleared Mar 21, 2014213-day reviewClass II21 CFR 878.4810

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 Mar 21, 2014 as substantially equivalent to K033437 (Allmed Systems, Inc., 2004) after a 213-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.

Decided: Mar 21, 2014
Review: 213 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K033437 (2004). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK033437 Sphinx Laser SystemsAllmed Systems, Inc. · 2004
This deviceK132607 NS 2500 Holmium Laser SystemNew Star Lasers, Inc. · 2014
Descendant · cites it directly · 0 of its ownK142286 NS3000 Holmium Laser SystemNew Star Lasers, Inc. · 2014 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K142286NS3000 Holmium Laser SystemNew Star Lasers, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K132607, 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K033437	Sphinx Laser Systems Summary page 1 …Panel: General and Plastic Surgery Product Code: GEX Ill. Predicate Device Ailmed Systems, Inc. Sphinx3O (K033437) IV. Device Description The New Star Model 2500 is a compact, portable, self-contained system that produces a…	Allmed Systems, Inc.	2004	—

Also cleared against K033437: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142286	NS3000 Holmium Laser System	New Star Lasers, Inc.	2014	0

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K142286 (New Star Lasers, Inc., 2014) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K033437.

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 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…

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 (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

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K132607 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132607: NS 2500 Holmium Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132607

Report an extraction error

Are you the manufacturer?

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