510(k) · Cleared
ClearedISL QC 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Surgical Lasers, Inc. · LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Cleared on Jun 15, 1989 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 67 later devices descend from it.
- Decided
- Jun 15, 1989
- Review
- 78 days
- Class
- Class II
- Product code
- LXS
- Recalls
- None
- Predicates
- 0
67 later devices descend from it, 2 citing it directly.
- This deviceK892058 ISL QC 2000Intelligent Surgical Lasers, Inc. · 1989
- Descendant · cites it directly · 66 of its ownK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- Descendant · 2 generations on · 65 of its ownK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- Descendant · 3 generations on · 61 of its ownK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- Descendant · 2 generations on · 58 of its ownK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- Descendant · 3 generations on · 57 of its ownK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K993153Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · cites it directly66descendants
- K013941Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · 2 generations on65descendants
- K031960Intralase FS LaserIntra Lase Corp. · 2003 · 3 generations on61descendants
- K060372Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006 · 2 generations on58descendants
- K063682Intralase Fusion LaserIntra Lase Corp. · 2007 · 3 generations on57descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K892058 | ISL QC 2000 | Intelligent Surgical Lasers, Inc. | 1989 | — |
| +1 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| +2 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| +3 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| +2 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| +3 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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 LXS? 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
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? (67)
See all 672 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K993153 (Intra Lase Corp., 1999) has gone furthest, with 66 descendants of its own.
How does its category compare?
All LXS devicesLXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXS
FDA has decided no LXS device since 2007.
Median 510(k) review, days · LXS
Too few LXS 510(k)s in any year since 2007 to give a median.
Recalls per year · LXS
No recall names LXS since 2007.
Adverse event reports per year · LXS
2in 2021
MAUDE reports naming product code LXS, 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 | 0 | — | 0 | 3 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 18 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K892058 · printed Nov 4, 2026
Cite this page
510(k) Report. “K892058: ISL QC 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K892058
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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