510(k) · Cleared
ClearedQ-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 31, 2005 as substantially equivalent to K011677 (Continuum Electro-Optics, Inc., 2001) and 2 other predicates after a 76-day review. Its family tree reaches back 5 generations to 1995. 39 later devices descend from it.
- Decided
- Jan 31, 2005
- Review
- 76 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K950019 (1995). 11 ancestors in all. 39 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- 4 generations backK973719 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag LaserContinuum Biomedical, Inc. · 1997
- 3 generations backK983054 Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag LaserContinuum Biomedical, Inc. · 1999
- 2 generations backK022709 Medlite Q-Swithced LaserContinuum Electro-Optics, Inc. · 2003
- 1 generation backK033259 Light Age Q-Clear Laser, Model 701-1101Light Age, Inc. · 2004
- This deviceK043173 Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesLumenis, Ltd. · 2005
- Descendant · cites it directly · 38 of its ownK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- Descendant · 2 generations on · 24 of its ownK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- Descendant · 3 generations on · 12 of its ownK193500 Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020
- Descendant · 3 generations on · 5 of its ownK203441 The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021
- Descendant · 4 generations on · 4 of its ownK202884 SR-1 Skin Treatment SystemAVAVA, Inc. · 2021
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K142860Lumenis M22 SystemLumenis, Ltd. · 2015 · cites it directly38descendants
- K170060M22 and ResurFx SystemsLumenis, Ltd. · 2017 · 2 generations on24descendants
- K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd. · 2020 · 3 generations on12descendants
- K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021 · 3 generations on5descendants
- K202884SR-1 Skin Treatment SystemAVAVA, Inc. · 2021 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| −4 | K973719 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser | Continuum Biomedical, Inc. | 1997 | — |
| −3 | K983054 | Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser | Continuum Biomedical, Inc. | 1999 | — |
| −2 | K022709 | Medlite Q-Swithced Laser | Continuum Electro-Optics, Inc. | 2003 | — |
| −1 | K033259 | Light Age Q-Clear Laser, Model 701-1101 | Light Age, Inc. | 2004 | — |
| 0 (this device) | K043173 | Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum Series | Lumenis, Ltd. | 2005 | — |
| +1 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| +2 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| +3 | K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | Lumenis, Ltd. | 2020 | — |
| +3 | K203441 | The Alma Hybrid Laser System | Alma Lasers, Ltd. | 2021 | — |
| +4 | K202884 | SR-1 Skin Treatment System | AVAVA, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K011677 | Medlite Q-Switched ND:Yag Laser Replaced by the Medlite C3 Q-Swtiched ND:Yag LaserSummary page 2…itched Nd:YAG Laser Treatment Head for the Quantum series shares the same indications for use as the predicate MedLite C3 Q-switched Nd:YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460), in that the 1064rnm wavelength is indicated… | 2001 |
| * | K033259 | Light Age Q-Clear Laser, Model 701-1101Summary page 2…or the Quantum series shares the same indications for use as the predicate MedLite C3 Q-switched Nd:YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460), in that the 1064rnm wavelength is indicated for: · Removal of dark tatt… | 2004 |
| * | K003460 | Palomar Clear Light ND: Yag Laser SystemSummary page 1…formerly Continuum Electro-Optics) * Light-Age Q-Clear laser (1(033259) marketed by Light Age Inc. * Q-YAG 5 laser (formerly Clear Light)(K003460, 1(023967) marketed by Palomar Medical Technologies Inc. IV. Product Description The Lumenis Quan… | 2001 |
What descends from it? (39)
See all 391 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142860 | Lumenis M22 System | 2015 | 38 |
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?
- The line of descent spans 10 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K142860 (Lumenis, Ltd., 2015) has gone furthest, with 38 descendants of its own.
- 9 other devices also cite its predicate K011677.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 Q-switched Nd:YAG Laser Treatment Head for the Quantum series in indicated for:
Removal of dark tattoos
Treatment of pigmented lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043173: Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043173
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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