510(k) · Cleared

Cleared

Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)

K020021510(k) TraditionalCleared Jul 2, 2002180-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

Laserscope · GEX Powered Laser Surgical Instrument

Cleared on Jul 2, 2002 as substantially equivalent to K003715 (Cooltouch Corp., 2001) and 1 other predicate after a 180-day review. Its family tree reaches back 1 generation to 2000. 740 later devices descend from it.

Decided: Jul 2, 2002
Review: 180 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K000811 (2000). 2 ancestors in all. 740 later devices descend from it, 15 citing it directly.

By dateBy generation

Root · 1 generation backK000811 Nlite System, SLS Model Number A00-1025Sls Biophile, Ltd. · 2000
This deviceK020021 Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Laserscope · 2002
Descendant · cites it directly · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
Descendant · cites it directly · 657 of its ownK022951 Candela Gentle Yag Laser System, Variable Pulse YagCandela Corp. · 2003
Descendant · cites it directly · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
Descendant · cites it directly · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
Descendant · 2 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004

Showing 5 of 740 descendants. See all descendants

Descendants cleared per year

2002high 84 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 740 · See all

K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · cites it directly665descendants
K022951Candela Gentle Yag Laser System, Variable Pulse YagCandela Corp. · 2003 · cites it directly657descendants
K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · cites it directly654descendants
K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · cites it directly519descendants
K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 2 generations on517descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000811	Nlite System, SLS Model Number A00-1025	Sls Biophile, Ltd.	2000	—
0 (this device)	K020021	Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)	Laserscope	2002	—
+1	K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…	Altus Medical, Inc.	2002	—
+1	K022951	Candela Gentle Yag Laser System, Variable Pulse Yag	Candela Corp.	2003	—
+1	K033172	Candela Gentleyag Family of Laser Systems	Candela Corp.	2003	—
+1	K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	—
+2	K042000	Modified MSQ Family of Lovely Light/Laser Systems	Msq (M2), Ltd.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	10	0
2004	6	0
2005	5	0
2006	6	0
2007	16	0
2008	26	0
2009	16	0
2010	19	0
2011	25	0
2012	22	0
2013	29	0
2014	31	0
2015	27	0
2016	39	0
2017	33	0
2018	33	0
2019	24	0
2020	42	0
2021	32	0
2022	54	0
2023	42	0
2024	71	0
2025	84	0
2026	47	0

FIG. 1 — Lineage of K020021, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K9990903	Lyra Surgical Laser System Number could not be read Summary page 2 …tem & Accessories is substantially equivalent in technology andintended use to the LyraT" Surgical Laser System FDA cleared under 5 10(k) K9990903, the CoolTouch Nd:YAG Laser System FDA cleared under 5 10(k) K003715, and the SLS NLite System FD…
*	K003715	Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch… Summary page 2 …d use to the LyraT" Surgical Laser System FDA cleared under 5 10(k) K9990903, the CoolTouch Nd:YAG Laser System FDA cleared under 5 10(k) K003715, and the SLS NLite System FDA cleared under 5 1O(k) KO008 11. H. Indications For Use:…	Cooltouch Corp.	2001	—
*	K000811	Nlite System, SLS Model Number A00-1025	Sls Biophile, Ltd.	2000	—

Also cleared against K003715: 5 other devices →

What descends from it? (740)

See all 740

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

Number	Device	Applicant	Decided	Descendants
K022226	Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…	Altus Medical, Inc.	2002	665
K022951	Candela Gentle Yag Laser System, Variable Pulse Yag	Candela Corp.	2003	657
K033172	Candela Gentleyag Family of Laser Systems	Candela Corp.	2003	654
K033251	The Friendlylight ND: Yag Lasers	Innotech USA, Inc.	2004	519
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
K040384	Mydon C	Wavelight Laser Technologie AG	2004	51
K063828	Diomed Delta 25	Diomed, Ltd.	2007	5
K031828	Naturalase LP ND:Yag Laser	Focus Medical, LLC	2003	5

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?

None of the 2 ancestors has a recall.
Of its descendants, K022226 (Altus Medical, Inc., 2002) has gone furthest, with 665 descendants of its own.
5 other devices also cite its predicate K003715.

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	—

What is it indicated for?

The Laserscope LyraTMLaser Systems & Accessories are indicated for use in the Dermatological applications for the treatment of facial wrinkles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020021 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020021: Lyra Surgical Laser System and Accessiories (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/K020021

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026