510(k) Report

510(k) · Cleared

Cleared

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

K003765510(k) TraditionalCleared Mar 6, 200190-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 Mar 6, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 741 later devices descend from it.

Decided
Mar 6, 2001
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

741 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2002: 4 descendants cleared2003: 7 descendants cleared2016: 39 descendants cleared2025: 84 descendants cleared2007: 16 descendants cleared2022: 54 descendants cleared2006: 6 descendants cleared2011: 25 descendants cleared2005: 5 descendants cleared2008: 26 descendants cleared2004: 6 descendants cleared2009: 16 descendants cleared2012: 22 descendants cleared2014: 32 descendants cleared2017: 33 descendants cleared2013: 29 descendants cleared2010: 19 descendants cleared2015: 27 descendants cleared2023: 42 descendants cleared2020: 42 descendants cleared2018: 33 descendants cleared2019: 24 descendants cleared2024: 71 descendants cleared2021: 32 descendants cleared2026: 47 descendants cleared200020052010201520202025
  1. This deviceK003765 Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag…Laserscope · 2001
  2. Descendant · cites it directly · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  3. Descendant · 2 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
  4. Descendant · 2 generations on · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003
  5. Descendant · 2 generations on · 656 of its ownK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
  6. Descendant · cites it directly · 654 of its ownK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003

Showing 5 of 741 descendants. See all descendants

Descendants cleared per year

2002: 42003: 72004: 62005: 52006: 62007: 162008: 262009: 162010: 192011: 252012: 222013: 292014: 322015: 272016: 392017: 332018: 332019: 242020: 422021: 322022: 542023: 422024: 712025: 842026: 47
2002high 84 (2025) · low 4 (2002)2026

Most influential descendants

Showing 5 of 741 · See all
  • K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc. · 2002 · cites it directly739descendants
  • K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 2 generations on665descendants
  • K022923Candela Gentle Yag Laser SystemCandela Corp. · 2003 · 2 generations on656descendants
  • K023193Candela Gentle Yag Laser SystemCandela Corp. · 2002 · 2 generations on656descendants
  • K033172Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003 · cites it directly654descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003765Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Laserscope2001—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—
+2K022923Candela Gentle Yag Laser SystemCandela Corp.2003—
+2K023193Candela Gentle Yag Laser SystemCandela Corp.2002—
+1K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200240
200370
200460
200550
200660
2007160
2008260
2009160
2010190
2011250
2012220
2013290
2014320
2015270
2016390
2017330
2018330
2019240
2020420
2021320
2022540
2023420
2024710
2025840
2026470
FIG. 1 — Lineage of K003765, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (741)

See all 741

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

NumberDeviceApplicantDecidedDescendants
K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739
K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654
K023881Profile 1064 Laser SystemSciton, Inc2003227
K032220Adept 1064/532 LaserAdept Medical Concepts2003126
K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104
K032221Adept 1064/755 LaserAdept Medical Concepts20030
K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020

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, K014040 (Altus Medical, Inc., 2002) has gone furthest, with 739 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

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
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

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

More from Laserscope

60 FDA decisions under this applicant name. See the company

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  • K061646Laserscope Guided Delivery Device (GDD) Cystourethroscope & AccessoriesLaserscope · 2006
  • K034011Gemini Surgical Laser System & AccessoriesLaserscope · 2004
  • K024206Aura Isurgical Laser System & AccessoriesLaserscope · 2003
  • K020021Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Laserscope · 2002

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The GEX category page

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https://510kreport.com/device/K003765 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003765: 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 4, 2026. https://510kreport.com/device/K003765

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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