510(k) · Cleared

Cleared

Incisor I Pulsed ND:Yag Laser System

K922901510(k) TraditionalCleared Nov 20, 1992157-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

Buckman Co., Inc. · GEX Powered Laser Surgical Instrument

Cleared on Nov 20, 1992 after a 157-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 320 later devices descend from it.

Decided: Nov 20, 1992
Review: 157 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

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

This deviceK922901 Incisor I Pulsed ND:Yag Laser SystemBuckman Co., Inc. · 1992
Descendant · cites it directly · 318 of its ownK972325 Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997
Descendant · 2 generations on · 280 of its ownK991994 TwilightBiolase Technology, Inc. · 1999
Descendant · 3 generations on · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
Descendant · cites it directly · 241 of its ownK974641 Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998
Descendant · 2 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002

Showing 5 of 320 descendants. See all descendants

Descendants cleared per year

1997high 32 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 320 · See all

K972325Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc. · 1997 · cites it directly318descendants
K991994TwilightBiolase Technology, Inc. · 1999 · 2 generations on280descendants
K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · 3 generations on246descendants
K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc. · 1998 · cites it directly241descendants
K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 2 generations on240descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K922901	Incisor I Pulsed ND:Yag Laser System	Buckman Co., Inc.	1992	—
+1	K972325	Pulsemaster 1000 ST Dental Laser System	American Dental Technologies, Inc.	1997	—
+2	K991994	Twilight	Biolase Technology, Inc.	1999	—
+3	K012511	Waterlase Millennium	Biolase Technology, Inc.	2002	—
+1	K974641	Futurelase 3000/3002 Erbium Laser System	Buckman Co., Inc.	1998	—
+2	K021508	Opusduo EC Dental Laser System	Opusdent, Ltd.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	2	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 K922901, 1992–2026Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (320)

See all 320

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

Number	Device	Applicant	Decided	Descendants
K972325	Pulsemaster 1000 ST Dental Laser System	American Dental Technologies, Inc.	1997	318
K974641	Futurelase 3000/3002 Erbium Laser System	Buckman Co., Inc.	1998	241

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, K972325 (American Dental Technologies, Inc., 1997) has gone furthest, with 318 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/K922901 · printed Nov 5, 2026

Cite this page

510(k) Report. “K922901: Incisor I Pulsed ND:Yag 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/K922901

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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