PMA · Approved
ApprovedThe Heart Laser TM CO2 Laser System for Transmyocardial Revascularization
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laser Engineering Heart, Inc. · MNO System, Laser, Transmyocardial Revascularization
Approved on Aug 20, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 1,220-day review.
- Decided
- Aug 20, 1998
- Review
- 1,220 days
- Class
- Class III
- Product code
- MNO
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P950015 has 10 supplements since 1998: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 1 |
| 2005 | 1 |
| 2009 | 1 |
| 2014 | 1 |
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 MNO? 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?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All MNO devicesMNO System, Laser, Transmyocardial Revascularization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MNO
Too few MNO 510(k)s in any year since 2007 to give a median.
Recalls per year · MNO
No recall names MNO since 2007.
Adverse event reports per year · MNO
2in 2022
MAUDE reports naming product code MNO, 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 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 5 | — | 0 | 15 |
| 2013 | 1 | — | 0 | 59 |
| 2014 | 3 | — | 0 | 27 |
| 2015 | 2 | — | 0 | 14 |
| 2016 | 3 | — | 0 | 6 |
| 2017 | 4 | — | 0 | 11 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P950015 · printed Nov 6, 2026
Cite this page
510(k) Report. “P950015: The Heart Laser TM CO2 Laser System for Transmyocardial Revascularization.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950015
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026