510(k) · Cleared
ClearedOphthalmed Bending Laser Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmed, LLC · HQF Laser, Ophthalmic
Cleared on Jun 25, 2015 as substantially equivalent to K021696 (Ophthalmed, LLC, 2002) and 3 other predicates after a 268-day review. Its family tree reaches back 4 generations to 1987. 2 later devices descend from it.
- Decided
- Jun 25, 2015
- Review
- 268 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K870942 (1987). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK870942 MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc. · 1987
- 3 generations backK982462 Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998
- 2 generations backK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
- 1 generation backK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
- This deviceK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
- Descendant · cites it directly · 1 of its ownK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK220263 Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser…Vortex Surgical, Inc. · 2022 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870942 | MVS Fiberoptic Lightpipe | Advanced Surgical Products, Inc. | 1987 | — |
| −3 | K982462 | Fiber Optic Endoillumination Probe | Microvision, Inc. | 1998 | — |
| −2 | K050807 | 20G Sma Laser Fiber, Model LF100 | Ophthalmed, LLC | 2005 | — |
| −1 | K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser Probes | Katalyst Surgical, LLC | 2012 | — |
| 0 (this device) | K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015 | — |
| +1 | K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019 | — |
| +2 | K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex… | Vortex Surgical, Inc. | 2022 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021696 | 20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25Summary page 4…gulatory class: II Product code: HQB III. PREDICATE DEVICE 510k number Trade or Proprietary or Model Name Manufacturer Primary predicate device K021696 LF20, LF25 OPHTHALMED LLC Yes K050807 LF100… | 2002 |
| * | K050807 | 20G Sma Laser Fiber, Model LF100Summary page 4…de or Proprietary or Model Name Manufacturer Primary predicate device K021696 LF20, LF25 OPHTHALMED LLC Yes K050807 LF100 OPHTHALMED LLC No K113857 Synergetics Directional Endo Ocular S… | 2005 |
| * | K113857 | Synergetics Directional Endoocular Laser ProbeSummary page 4…K021696 LF20, LF25 OPHTHALMED LLC Yes K050807 LF100 OPHTHALMED LLC No K113857 Synergetics Directional Endo Ocular SYNERGETICS No Laser Probe K121187 Katalyst l… | 2012 |
| * | K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser ProbesSummary page 4…OPHTHALMED LLC No K113857 Synergetics Directional Endo Ocular SYNERGETICS No Laser Probe K121187 Katalyst laser probes KATALYST SURGICAL No IV. DEVICE DESCRIPTION This laser probe is made out of 8ft… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191846 | MAXReach Laser Probe | 2019 | 1 |
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K191846 (Vortex Surgical, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K021696.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Ophthalmed Bending Laser Probes (Models A207000, A807000, and A307000) are indicated for performing laser endophotocoagulation in the posterior segment of the eye during vitreoretinal surgery at an operating wavelength range from 500 to 1100 nm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142830 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142830: Ophthalmed Bending Laser Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142830
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026