510(k) · Cleared
Recalled · Class II · 2015Lightsheer Pulsed Diode Array Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coherent Star · GEX Powered Laser Surgical Instrument
Cleared on Mar 13, 2001 after a 111-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 728 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 13, 2001
- Review
- 111 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 2
- Predicates
- 0
728 later devices descend from it, 10 citing it directly.
- This deviceK003614 Lightsheer Pulsed Diode Array Laser SystemCoherent Star · 2001
- Descendant · cites it directly · 363 of its ownK030805 Mythos 500Msq (M2), Ltd. · 2003
- Descendant · cites it directly · 301 of its ownK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- Descendant · 2 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · cites it directly · 297 of its ownK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
Showing 5 of 728 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 728 · See all- K030805Mythos 500Msq (M2), Ltd. · 2003 · cites it directly363descendants
- K041959Polaris DS/CometSyneron Medical, Ltd. · 2004 · cites it directly301descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 2 generations on299descendants
- K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006 · cites it directly297descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003614 | Lightsheer Pulsed Diode Array Laser System | Coherent Star | 2001 | — |
| +1 | K030805 | Mythos 500 | Msq (M2), Ltd. | 2003 | — |
| +1 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| +2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +1 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 13 | 0 |
| 2009 | 14 | 0 |
| 2010 | 15 | 0 |
| 2011 | 10 | 0 |
| 2012 | 18 | 0 |
| 2013 | 22 | 0 |
| 2014 | 31 | 0 |
| 2015 | 28 | 0 |
| 2016 | 36 | 0 |
| 2017 | 33 | 0 |
| 2018 | 36 | 0 |
| 2019 | 26 | 0 |
| 2020 | 38 | 0 |
| 2021 | 46 | 0 |
| 2022 | 62 | 0 |
| 2023 | 62 | 0 |
| 2024 | 77 | 0 |
| 2025 | 94 | 0 |
| 2026 | 51 | 0 |
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
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? (728)
See all 72810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030805 | Mythos 500 | 2003 | 363 |
| K041959 | Polaris DS/Comet | 2004 | 301 |
| K060448 | Lumenis One Family of Systems; Lumenis One. | 2006 | 297 |
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
| K020849 | Apex 800 Laser System, Model Apex 800 | 2002 | 174 |
| K011747 | Palomar LC 100 Diode Laser | 2001 | 174 |
| K083848 | Alma Lasers Soprano XL Multi-Application Platform | 2009 | 125 |
| K032991 | Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX | 2004 | 61 |
| K100893 | Cheveux Diode Laser System | 2010 | 8 |
| K073300 | Milesman Premium | 2007 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2015 | Class II | Z-1519-2015 | Software design | Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin… |
| Feb 9, 2006 | Not classified | Z-0556-06 | Other | During hair removal treatment, patients' skin can experience burns due to debris accumulating on the sapphire crystal tip. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K030805 (Msq (M2), Ltd., 2003) has gone furthest, with 363 descendants of its own.
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 | — |
https://510kreport.com/device/K003614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003614: Lightsheer Pulsed Diode Array 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/K003614
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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