510(k) · Cleared

Recalled · 2010

Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)

K010284510(k) TraditionalCleared May 1, 200190-day reviewClass II21 CFR 878.4810Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Laserscope · GEX Powered Laser Surgical Instrument

Cleared on May 1, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 357 later devices descend from it. It has been recalled 3 times.

Decided: May 1, 2001
Review: 90 days
Class: Class II
Product code: GEX
Recalls: 3
Predicates: 0

357 later devices descend from it, 5 citing it directly.

This deviceK010284 Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag…Laserscope · 2001
Descendant · cites it directly · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
Descendant · 2 generations on · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
Descendant · cites it directly · 227 of its ownK023881 Profile 1064 Laser SystemSciton, Inc · 2003
Descendant · 2 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Descendant · 3 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008

Showing 5 of 357 descendants. See all descendants

Descendants cleared per year

2003high 54 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 357 · See all

K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · cites it directly230descendants
K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · 2 generations on229descendants
K023881Profile 1064 Laser SystemSciton, Inc · 2003 · cites it directly227descendants
K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 2 generations on221descendants
K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 3 generations on202descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010284	Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)	Laserscope	2001	—
+1	K071295	100W Ceralas D 980NM Diode Laser	Biolitec, Inc.	2007	—
+2	K072106	150W Ceralas D 980NM Diode Laser	Biolitec, Inc.	2007	—
+1	K023881	Profile 1064 Laser System	Sciton, Inc	2003	—
+2	K060033	Profile Multi-Platform System	Sciton, Inc	2006	—
+3	K073063	15W Ceralas D 1470NM Diode Laser	Biolitec, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	4	0
2004	1	0
2005	2	0
2006	2	0
2007	6	0
2008	13	0
2009	8	0
2010	9	0
2011	6	0
2012	6	0
2013	15	0
2014	12	0
2015	14	0
2016	14	0
2017	14	0
2018	18	0
2019	14	0
2020	22	0
2021	12	0
2022	30	0
2023	18	0
2024	35	0
2025	54	0
2026	28	0

FIG. 1 — Lineage of K010284, 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? (357)

See all 357

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

Number	Device	Applicant	Decided	Descendants
K071295	100W Ceralas D 980NM Diode Laser	Biolitec, Inc.	2007	230
K023881	Profile 1064 Laser System	Sciton, Inc	2003	227
K032220	Adept 1064/532 Laser	Adept Medical Concepts	2003	126
K032218	Adept 1064/532/755 Laser	Adept Medical Concepts	2003	104
K032221	Adept 1064/755 Laser	Adept Medical Concepts	2003	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 8, 2010	Not classified	Z-1229-2011	Other	A failure mode whereby the fiber attachment to the GreenLight PV laser system could inadvertently be broken. If fiber were to bend sharply at point of fiber connection, it may break and cause a burn.
Jun 18, 2007	Not classified	Z-0131-2008	Process design	Control knob break: The knob used to finely control the direction of the laser energy may break.
Apr 17, 2007	Not classified	Z-0130-2008	Process design	Component missing: Some products were issued without thermal protection switches.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K071295 (Biolitec, Inc., 2007) has gone furthest, with 230 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/K010284 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010284: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010284

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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