510(k) · Cleared

Cleared

Optilase Model 1000-100 ND: Yag Laser System

K932883510(k) TraditionalCleared Jun 21, 1994372-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

Trimedyne, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jun 21, 1994 after a 372-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 197 later devices descend from it.

Decided: Jun 21, 1994
Review: 372 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

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

This deviceK932883 Optilase Model 1000-100 ND: Yag Laser SystemTrimedyne, Inc. · 1994
Descendant · cites it directly · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Descendant · 3 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
Descendant · 2 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
Descendant · 4 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015

Showing 5 of 197 descendants. See all descendants

Descendants cleared per year

1996high 26 (2025) · low 0 (1998)2026

Most influential descendants

Showing 5 of 197 · See all

K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · cites it directly192descendants
K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 3 generations on70descendants
K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 2 generations on68descendants
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 4 generations on62descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K932883	Optilase Model 1000-100 ND: Yag Laser System	Trimedyne, Inc.	1994	—
+1	K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	—
+2	K101916	Joule Multi-Platform System	Sciton, Inc	2011	—
+3	K132806	Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece	Fotona D.D.	2014	—
+2	K100558	Quanta Diode Laser System	Quanta System Spa	2010	—
+4	K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1999	1	0
2005	1	0
2008	1	0
2010	5	0
2011	4	0
2012	4	0
2013	7	0
2014	8	0
2015	10	0
2016	10	0
2017	6	0
2018	11	0
2019	7	0
2020	14	0
2021	9	0
2022	23	0
2023	11	0
2024	22	0
2025	26	0
2026	15	0

FIG. 1 — Lineage of K932883, 1994–2026Source: 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? (197)

See all 197

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

Number	Device	Applicant	Decided	Descendants
K083613	Quanta System Polysurge Diode Laser Family	Quanta System Spa	2008	192
K954597	Right Angle Laser Fibers	Trimedyne, Inc.	1996	4

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, K083613 (Quanta System Spa, 2008) has gone furthest, with 192 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/K932883 · printed Nov 4, 2026

Cite this page

510(k) Report. “K932883: Optilase Model 1000-100 ND: Yag 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/K932883

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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