510(k) · Cleared

Cleared

Waterlase, Millennium

K011041510(k) TraditionalCleared Jul 3, 200189-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

Biolase Technology, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 3, 2001 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 373 later devices descend from it.

Decided: Jul 3, 2001
Review: 89 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

373 later devices descend from it, 4 citing it directly.

This deviceK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
Descendant · cites it directly · 327 of its ownK030539 LasersmileBiolase Technology, Inc. · 2003
Descendant · 2 generations on · 289 of its ownK061898 EzlaseBiolase Technology, Inc. · 2007
Descendant · 3 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
Descendant · cites it directly · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
Descendant · 2 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004

Showing 5 of 373 descendants. See all descendants

Descendants cleared per year

2002high 47 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 373 · See all

K030539LasersmileBiolase Technology, Inc. · 2003 · cites it directly327descendants
K061898EzlaseBiolase Technology, Inc. · 2007 · 2 generations on289descendants
K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 3 generations on263descendants
K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · cites it directly240descendants
K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 2 generations on226descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011041	Waterlase, Millennium	Biolase Technology, Inc.	2001	—
+1	K030539	Lasersmile	Biolase Technology, Inc.	2003	—
+2	K061898	Ezlase	Biolase Technology, Inc.	2007	—
+3	K072034	Diode Medical Laser Family, Models 4, 6, 30	Quanta System Spa	2007	—
+1	K021508	Opusduo EC Dental Laser System	Opusdent, Ltd.	2002	—
+2	K040270	Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum	Lumenis, Ltd.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	2	0
2005	1	0
2006	6	0
2007	9	0
2008	19	0
2009	11	0
2010	17	0
2011	11	0
2012	9	0
2013	16	0
2014	16	0
2015	17	0
2016	12	0
2017	13	0
2018	17	0
2019	13	0
2020	21	0
2021	13	0
2022	28	0
2023	18	0
2024	31	0
2025	47	0
2026	24	0

FIG. 1 — Lineage of K011041, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (373)

See all 373

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

Number	Device	Applicant	Decided	Descendants
K030539	Lasersmile	Biolase Technology, Inc.	2003	327
K021508	Opusduo EC Dental Laser System	Opusdent, Ltd.	2002	240
K030523	Waterlase	Biolase Technology, Inc.	2004	8
K052354	Oculase MD	Biolase Technology, Inc.	2006	5

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?

Of its descendants, K030539 (Biolase Technology, Inc., 2003) has gone furthest, with 327 descendants of its own.

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	—

https://510kreport.com/device/K011041 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011041: Waterlase, Millennium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011041

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026