510(k) · Cleared

Cleared

Opus 20, Model 1ST

K002899510(k) TraditionalCleared Dec 12, 200085-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

Opusdent, Ltd. · GEX Powered Laser Surgical Instrument

Cleared on Dec 12, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 242 later devices descend from it.

Decided: Dec 12, 2000
Review: 85 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

242 later devices descend from it, 2 citing it directly.

This deviceK002899 Opus 20, Model 1STOpusdent, Ltd. · 2000
Descendant · cites it directly · 241 of its ownK014100 Opus Spectrum (a Model of Opus 20), Model 2NDOpusdent, Ltd. · 2002
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
Descendant · 3 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · 4 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008

Showing 5 of 242 descendants. See all descendants

Descendants cleared per year

2002high 29 (2025) · low 0 (2003)2026

Most influential descendants

Showing 5 of 242 · See all

K014100Opus Spectrum (a Model of Opus 20), Model 2NDOpusdent, Ltd. · 2002 · cites it directly241descendants
K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · cites it directly240descendants
K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 2 generations on226descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 3 generations on221descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 4 generations on202descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002899	Opus 20, Model 1ST	Opusdent, Ltd.	2000	—
+1	K014100	Opus Spectrum (a Model of Opus 20), Model 2ND	Opusdent, Ltd.	2002	—
+1	K021508	Opusduo EC Dental Laser System	Opusdent, Ltd.	2002	—
+2	K040270	Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum	Lumenis, Ltd.	2004	—
+3	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+4	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2004	1	0
2006	2	0
2007	3	0
2008	10	0
2009	4	0
2010	9	0
2011	7	0
2012	4	0
2013	10	0
2014	11	0
2015	12	0
2016	10	0
2017	7	0
2018	13	0
2019	7	0
2020	14	0
2021	10	0
2022	24	0
2023	14	0
2024	24	0
2025	29	0
2026	15	0

FIG. 1 — Lineage of K002899, 2000–2026Source: 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? (242)

See all 242

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

Number	Device	Applicant	Decided	Descendants
K014100	Opus Spectrum (a Model of Opus 20), Model 2ND	Opusdent, Ltd.	2002	241
K021508	Opusduo EC Dental Laser System	Opusdent, Ltd.	2002	240

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, K014100 (Opusdent, Ltd., 2002) has gone furthest, with 241 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/K002899 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002899: Opus 20, Model 1ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002899

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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