PMA · Approved
ApprovedMicroruptor MR-2 ND:Yag Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian AG · LOI Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
Approved on Jan 31, 1986 through premarket approval, which rests on the device’s own clinical evidence after a 683-day review. 9 later devices descend from it.
- Decided
- Jan 31, 1986
- Review
- 683 days
- Class
- Class III
- Product code
- LOI
- Recalls
- None
9 later devices descend from it, 1 citing it directly.
- This deviceP840012 Microruptor MR-2 ND:Yag Laser SystemMeridian AG · 1986
- Descendant · cites it directly · 8 of its ownK973470 Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic…Lumenis, Inc. · 1997
- Descendant · 2 generations on · 5 of its ownK032357 Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003
- Descendant · 3 generations on · 4 of its ownK052526 Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005
- Descendant · 4 generations on · 1 of its ownK062336 Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006
- Descendant · 4 generations on · 1 of its ownK061025 Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K973470Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in…Lumenis, Inc. · 1997 · cites it directly8descendants
- K032357Novus TTX Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2003 · 2 generations on5descendants
- K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc. · 2005 · 3 generations on4descendants
- K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006 · 4 generations on1descendant
- K061025Accutech Endolite ProbeAccutech Medical Technologies, Inc. · 2006 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P840012 | Microruptor MR-2 ND:Yag Laser System | Meridian AG | 1986 | — |
| +1 | K973470 | Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser… | Lumenis, Inc. | 1997 | — |
| +2 | K032357 | Novus TTX Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2003 | — |
| +3 | K052526 | Novus 3000 Laser System and Delivery Devices | Lumenis, Inc. | 2005 | — |
| +4 | K062336 | Optimedica Laser Indirect Ophthalmoscope | Optimedica Corporation | 2006 | — |
| +4 | K061025 | Accutech Endolite Probe | Accutech Medical Technologies, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 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 LOI? 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? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973470 | Coherent Popeye Ophthalmic Laser System, Coherent Popeye Ophthalmic Laser System in… | 1997 | 8 |
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, K973470 (Lumenis, Inc., 1997) has gone furthest, with 8 descendants of its own.
How does its category compare?
All LOI devicesLOI Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOI
FDA has decided no LOI device since 2007.
Median 510(k) review, days · LOI
Too few LOI 510(k)s in any year since 2007 to give a median.
Recalls per year · LOI
No recall names LOI since 2007.
Adverse event reports per year · LOI
No MAUDE report names LOI since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P840012 · printed Nov 4, 2026
Cite this page
510(k) Report. “P840012: Microruptor MR-2 ND:Yag Laser System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P840012
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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