PMA · Approved
ApprovedSpectranectics CVX-300 Excimer Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectranetics Corp. · LPC Device, Angioplasty, Laser, Coronary
Approved on Feb 19, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 742-day review. 767 later devices descend from it.
- Decided
- Feb 19, 1993
- Review
- 742 days
- Class
- Class III
- Product code
- LPC
- Recalls
- None
767 later devices descend from it, 1 citing it directly.
- This deviceP910001 Spectranectics CVX-300 Excimer Laser SystemSpectranetics Corp. · 1993
- Descendant · cites it directly · 766 of its ownK992914 Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000
- Descendant · 2 generations on · 759 of its ownK020591 BclearLumenis · 2002
- Descendant · 2 generations on · 750 of its ownK021762 BclearLumenis, Inc. · 2002
- Descendant · 3 generations on · 737 of its ownK033946 Lovely SystemMsq (M2), Ltd. · 2004
- Descendant · 3 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
Showing 5 of 767 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 767 · See all- K992914Excimer Laser Phototherapy System, AL7000Acculase, Inc. · 2000 · cites it directly766descendants
- K020591BclearLumenis · 2002 · 2 generations on759descendants
- K021762BclearLumenis, Inc. · 2002 · 2 generations on750descendants
- K033946Lovely SystemMsq (M2), Ltd. · 2004 · 3 generations on737descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 3 generations on517descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P910001 | Spectranectics CVX-300 Excimer Laser System | Spectranetics Corp. | 1993 | — |
| +1 | K992914 | Excimer Laser Phototherapy System, AL7000 | Acculase, Inc. | 2000 | — |
| +2 | K020591 | Bclear | Lumenis | 2002 | — |
| +2 | K021762 | Bclear | Lumenis, Inc. | 2002 | — |
| +3 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| +3 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 16 | 0 |
| 2008 | 24 | 0 |
| 2009 | 14 | 0 |
| 2010 | 17 | 0 |
| 2011 | 18 | 0 |
| 2012 | 15 | 0 |
| 2013 | 24 | 0 |
| 2014 | 27 | 0 |
| 2015 | 26 | 0 |
| 2016 | 35 | 0 |
| 2017 | 35 | 0 |
| 2018 | 34 | 0 |
| 2019 | 23 | 0 |
| 2020 | 46 | 0 |
| 2021 | 37 | 0 |
| 2022 | 50 | 0 |
| 2023 | 49 | 0 |
| 2024 | 82 | 0 |
| 2025 | 105 | 0 |
| 2026 | 67 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (767)
See all 7671 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992914 | Excimer Laser Phototherapy System, AL7000 | 2000 | 766 |
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, K992914 (Acculase, Inc., 2000) has gone furthest, with 766 descendants of its own.
How does its category compare?
All LPC devicesLPC Device, Angioplasty, Laser, Coronary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPC
Too few LPC 510(k)s in any year since 2007 to give a median.
Recalls per year · LPC
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPC
17in 2025
MAUDE reports naming product code LPC, 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 | 1 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 4 |
| 2009 | 3 | — | 0 | 5 |
| 2010 | 4 | — | 0 | 1 |
| 2011 | 10 | — | 0 | 10 |
| 2012 | 11 | — | 1 | 2 |
| 2013 | 5 | — | 0 | 7 |
| 2014 | 7 | — | 0 | 15 |
| 2015 | 7 | — | 0 | 15 |
| 2016 | 7 | — | 1 | 12 |
| 2017 | 10 | — | 0 | 21 |
| 2018 | 8 | — | 0 | 16 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 7 |
| 2022 | 4 | — | 1 | 15 |
| 2023 | 4 | — | 0 | 23 |
| 2024 | 2 | — | 0 | 12 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 3 | — | 0 | — |
https://510kreport.com/device/P910001 · printed Nov 4, 2026
Cite this page
510(k) Report. “P910001: Spectranectics CVX-300 Excimer Laser System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P910001
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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