510(k) · Cleared

Cleared

Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM

K000317510(k) TraditionalCleared Oct 27, 2000269-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

Tissue Medical Lasers, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Oct 27, 2000 after a 269-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 240 later devices descend from it.

Decided: Oct 27, 2000
Review: 269 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

240 later devices descend from it, 3 citing it directly.

This deviceK000317 Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRMTissue Medical Lasers, Inc. · 2000
Descendant · cites it directly · 168 of its ownK053139 Fotona QX ND:Yag/KTP Laser SystemFotona D.D. · 2006
Descendant · 2 generations on · 166 of its ownK083889 Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009
Descendant · 3 generations on · 92 of its ownK103455 Spectra Laser SystemLutronic Corporation · 2011
Descendant · 4 generations on · 82 of its ownK113588 Spectra Laser SystemLutronic Corporation · 2012
Descendant · cites it directly · 76 of its ownK033259 Light Age Q-Clear Laser, Model 701-1101Light Age, Inc. · 2004

Showing 5 of 240 descendants. See all descendants

Descendants cleared per year

2004high 36 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 240 · See all

K053139Fotona QX ND:Yag/KTP Laser SystemFotona D.D. · 2006 · cites it directly168descendants
K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D. · 2009 · 2 generations on166descendants
K103455Spectra Laser SystemLutronic Corporation · 2011 · 3 generations on92descendants
K113588Spectra Laser SystemLutronic Corporation · 2012 · 4 generations on82descendants
K033259Light Age Q-Clear Laser, Model 701-1101Light Age, Inc. · 2004 · cites it directly76descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000317	Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM	Tissue Medical Lasers, Inc.	2000	—
+1	K053139	Fotona QX ND:Yag/KTP Laser System	Fotona D.D.	2006	—
+2	K083889	Fotona QX ND:Yag/KTP Laser System Family	Fotona D.D.	2009	—
+3	K103455	Spectra Laser System	Lutronic Corporation	2011	—
+4	K113588	Spectra Laser System	Lutronic Corporation	2012	—
+1	K033259	Light Age Q-Clear Laser, Model 701-1101	Light Age, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	2	0
2009	2	0
2011	2	0
2012	3	0
2013	2	0
2014	5	0
2015	5	0
2016	17	0
2017	14	0
2018	12	0
2019	9	0
2020	18	0
2021	18	0
2022	26	0
2023	18	0
2024	27	0
2025	36	0
2026	22	0

FIG. 1 — Lineage of K000317, 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? (240)

See all 240

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

Number	Device	Applicant	Decided	Descendants
K053139	Fotona QX ND:Yag/KTP Laser System	Fotona D.D.	2006	168
K033259	Light Age Q-Clear Laser, Model 701-1101	Light Age, Inc.	2004	76
K061850	Mini-Yag Laser	American Lasers, Inc.	2006	0

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, K053139 (Fotona D.D., 2006) has gone furthest, with 168 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/K000317 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000317: Spectra-VRM Q-Switched ND:Yag Laser System, Spectra-VRM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000317

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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