510(k) Report

510(k) · Cleared

Cleared

Modified Luxar LX-20 Family CO2 Laser System

K953074510(k) TraditionalCleared Aug 28, 199559-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

Luxar Corp. · GEX Powered Laser Surgical Instrument

Cleared on Aug 28, 1995 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 407 later devices descend from it.

Decided
Aug 28, 1995
Review
59 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

407 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 2 descendants cleared2012: 11 descendants cleared2004: 4 descendants cleared2010: 7 descendants cleared2008: 16 descendants cleared2006: 7 descendants cleared2014: 13 descendants cleared2005: 3 descendants cleared2002: 3 descendants cleared1999: 2 descendants cleared2009: 8 descendants cleared2011: 14 descendants cleared2023: 25 descendants cleared2018: 22 descendants cleared2000: 1 descendant cleared2007: 12 descendants cleared2025: 41 descendants cleared2003: 3 descendants cleared2013: 11 descendants cleared2015: 12 descendants cleared2021: 22 descendants cleared2016: 13 descendants cleared2022: 36 descendants cleared2024: 41 descendants cleared2020: 28 descendants cleared2017: 13 descendants cleared2019: 10 descendants cleared2026: 26 descendants cleared1995200020052010201520202025
  1. This deviceK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
  2. Descendant · cites it directly · 403 of its ownK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
  3. Descendant · 2 generations on · 377 of its ownK991628 Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc. · 1999
  4. Descendant · 3 generations on · 376 of its ownK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
  5. Descendant · 4 generations on · 323 of its ownK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
  6. Descendant · 4 generations on · 318 of its ownK031795 Reliant Laser SystemReliant Technologies, Inc. · 2003

Showing 5 of 407 descendants. See all descendants

Descendants cleared per year

1996: 11997: 21999: 22000: 12002: 32003: 32004: 42005: 32006: 72007: 122008: 162009: 82010: 72011: 142012: 112013: 112014: 132015: 122016: 132017: 132018: 222019: 102020: 282021: 222022: 362023: 252024: 412025: 412026: 26
1996high 41 (2024) · low 0 (1998)2026

Most influential descendants

Showing 5 of 407 · See all
  • K960475Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996 · cites it directly403descendants
  • K991628Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc. · 1999 · 2 generations on377descendants
  • K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesLumenis, Inc. · 2002 · 3 generations on376descendants
  • K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003 · 4 generations on323descendants
  • K031795Reliant Laser SystemReliant Technologies, Inc. · 2003 · 4 generations on318descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K953074Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp.1995—
+1K960475Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp.1996—
+2K991628Modified LX-20 CO2 Laser System Family, LX-20SAEsc Medical Systems, Inc.1999—
+3K022060Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device…Lumenis, Inc.2002—
+4K030147Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd.2003—
+4K031795Reliant Laser SystemReliant Technologies, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199720
199920
200010
200230
200330
200440
200530
200670
2007120
2008160
200980
201070
2011140
2012110
2013110
2014130
2015120
2016130
2017130
2018220
2019100
2020280
2021220
2022360
2023250
2024410
2025410
2026260
FIG. 1 — Lineage of K953074, 1995–2026Source: 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
Get a 510(k) Report

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? (407)

See all 407

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

NumberDeviceApplicantDecidedDescendants
K960475Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp.1996403
K040563LS Family of CO2 Lasers Including: LS-15 Laser System (15 Watt) and LS-25 Laser System…Sandstone Medical Technologies, LLC20045
K123037LightscalpelLightscalpel, LLC20124
K042439Azuryt Model CLT 1401, CO2 Surgical Laser SystemDiamond Age Systems, Inc.20041
K121580Surelase CO2 Laser SystemClinicon Corp.20120
K971821Unica 315 M CO2 Surgical Laser SystemReliant Technologies, Inc.19970

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, K960475 (Luxar Corp., 1996) has gone furthest, with 403 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 Luxar Corp.

17 FDA decisions under this applicant name. See the company

  • K960475Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
  • K945888Modified Luxar LX-20 Family C02 Laser SystemLuxar Corp. · 1995
  • K904068Luxar Model LX-20 CO2 LaserLuxar Corp. · 1991
  • K903079Endoguide (R), Microguide (TM), Flexiguide (TM)Luxar Corp. · 1990
  • K900066Flexiguide (TM) CO2 Laser Hollow Flexible FiberLuxar Corp. · 1990

Recent decisions in GEX

The GEX category page

  • K262701PicoPeak Picosecond Nd:Yag Laser System (Bella-9)Beijing Sea Heart International Science and Technologyco.Ltd · 2026
  • K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd. · 2026
  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K953074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K953074: Modified Luxar LX-20 Family CO2 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K953074

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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