510(k) · Cleared

Cleared

Aurora Diode Laser System

K974586510(k) TraditionalCleared Jul 15, 1998218-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

Premier Laser Systems, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 15, 1998 as substantially equivalent to K954316 (Premier Laser Systems, Inc., 1995) after a 218-day review. Its family tree reaches back 1 generation to 1995. 318 later devices descend from it.

Decided: Jul 15, 1998
Review: 218 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954316 (1995). 318 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK954316 Aurora Surgical Diode Laser System W/AccessoriesPremier Laser Systems, Inc. · 1995
This deviceK974586 Aurora Diode Laser SystemPremier Laser Systems, Inc. · 1998
Descendant · cites it directly · 280 of its ownK991994 TwilightBiolase Technology, Inc. · 1999
Descendant · 2 generations on · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
Descendant · 3 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
Descendant · 4 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
Descendant · 5 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006

Showing 5 of 318 descendants. See all descendants

Descendants cleared per year

1998high 32 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 318 · See all

K991994TwilightBiolase Technology, Inc. · 1999 · cites it directly280descendants
K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · 2 generations on246descendants
K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 3 generations on240descendants
K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 4 generations on226descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 5 generations on221descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954316	Aurora Surgical Diode Laser System W/Accessories	Premier Laser Systems, Inc.	1995	—
0 (this device)	K974586	Aurora Diode Laser System	Premier Laser Systems, Inc.	1998	—
+1	K991994	Twilight	Biolase Technology, Inc.	1999	—
+2	K012511	Waterlase Millennium	Biolase Technology, Inc.	2002	—
+3	K021508	Opusduo EC Dental Laser System	Opusdent, Ltd.	2002	—
+4	K040270	Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum	Lumenis, Ltd.	2004	—
+5	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2002	2	0
2003	1	0
2004	2	0
2006	4	0
2007	7	0
2008	18	0
2009	8	0
2010	15	0
2011	11	0
2012	8	0
2013	14	0
2014	14	0
2015	13	0
2016	11	0
2017	12	0
2018	15	0
2019	11	0
2020	17	0
2021	12	0
2022	27	0
2023	15	0
2024	26	0
2025	32	0
2026	20	0

FIG. 1 — Lineage of K974586, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (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
*	K954316	Aurora Surgical Diode Laser System W/Accessories Summary page 3 …- REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET. NOTE: This is an additional indication to the indications cleared for market release in 510(k) 954316. (PLEASE DO NOT WRITE BEL OW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of C Prescription Use \( DRH, Offig…	Premier Laser Systems, Inc.	1995	—

Also cleared against K954316: 6 other devices →

What descends from it? (318)

See all 318

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K991994	Twilight	Biolase Technology, Inc.	1999	280
K983058	Ceralas D Laser System, Model # Ceralas D15	Ceram Optec, Inc.	1998	208

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, K991994 (Biolase Technology, Inc., 1999) has gone furthest, with 280 descendants of its own.
6 other devices also cite its predicate K954316.

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.

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?

SULCULAR DEBRIDEMENT - REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET.

NOTE: This is an additional indication to the indications cleared for market release in 510(k) 954316.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974586 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974586: Aurora Diode Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974586

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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