510(k) · Cleared
ClearedInfinitech Aspirating Laser Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Technologies, Inc. · HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Cleared on Apr 18, 1995 after a 123-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- Apr 18, 1995
- Review
- 123 days
- Class
- Class II
- Product code
- HQE
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK946135 Infinitech Aspirating Laser ProbeSurgical Technologies, Inc. · 1995
- Descendant · cites it directly · 6 of its ownK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
- Descendant · 2 generations on · 5 of its ownK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK022228 Family of Iris Medical Endoprobe HandpiecesIridex Corp · 2002
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K05080720G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005 · cites it directly6descendants
- K121187Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012 · 2 generations on5descendants
- K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015 · 2 generations on2descendants
- K191846MAXReach Laser ProbeVortex Surgical, Inc. · 2019 · 3 generations on1descendant
- K022228Family of Iris Medical Endoprobe HandpiecesIridex Corp · 2002 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K946135 | Infinitech Aspirating Laser Probe | Surgical Technologies, Inc. | 1995 | — |
| +1 | K050807 | 20G Sma Laser Fiber, Model LF100 | Ophthalmed, LLC | 2005 | — |
| +2 | K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser Probes | Katalyst Surgical, LLC | 2012 | — |
| +2 | K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015 | — |
| +3 | K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019 | — |
| +1 | K022228 | Family of Iris Medical Endoprobe Handpieces | Iridex Corp | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 1 | 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 HQE? 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 HQE device
- #1 K212763 UniVit HE, UniVit UHSscore 4.1 · 2 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
3 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, K050807 (Ophthalmed, LLC, 2005) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HQE devicesHQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQE
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQE
Too few HQE 510(k)s in any year since 2007 to give a median.
Recalls per year · HQE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQE
339in 2025
MAUDE reports naming product code HQE, 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 | — | 2 | 300 |
| 2008 | 0 | — | 0 | 65 |
| 2009 | 0 | — | 0 | 34 |
| 2010 | 0 | — | 11 | 27 |
| 2011 | 1 | — | 0 | 21 |
| 2012 | 2 | — | 0 | 34 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 1 | — | 4 | 10 |
| 2017 | 1 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 309 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 0 | — | 0 | 30 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 108 |
| 2024 | 0 | — | 0 | 105 |
| 2025 | 0 | — | 1 | 339 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K946135 · printed Nov 6, 2026
Cite this page
510(k) Report. “K946135: Infinitech Aspirating Laser Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K946135
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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