510(k) · Cleared
Cleared20G Sma Laser Fiber, Model LF100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophthalmed, LLC · HQF Laser, Ophthalmic
Cleared on Sep 21, 2005 as substantially equivalent to K021696 (Ophthalmed, LLC, 2002) and 2 other predicates after a 175-day review. Its family tree reaches back 2 generations to 1987. 6 later devices descend from it.
- Decided
- Sep 21, 2005
- Review
- 175 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K870942 (1987). 5 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK870942 MVS Fiberoptic LightpipeAdvanced Surgical Products, Inc. · 1987
- 1 generation backK982462 Fiber Optic Endoillumination ProbeMicrovision, Inc. · 1998
- This deviceK050807 20G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
- Descendant · cites it directly · 5 of its ownK121187 Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012
- Descendant · cites it directly · 2 of its ownK142830 Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK191846 MAXReach Laser ProbeVortex Surgical, Inc. · 2019
- Descendant · 3 generations on · 0 of its ownK220263 Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser…Vortex Surgical, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK182646 Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K121187Katalyst Laser Probes, Katalyst Illuminated Laser ProbesKatalyst Surgical, LLC · 2012 · cites it directly5descendants
- K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015 · cites it directly2descendants
- K191846MAXReach Laser ProbeVortex Surgical, Inc. · 2019 · 2 generations on1descendant
- K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical…Vortex Surgical, Inc. · 2022 · 3 generations on0descendants
- K182646Vitreq disposable laser probes, light fibers and ChandelierVitreQ BV · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K870942 | MVS Fiberoptic Lightpipe | Advanced Surgical Products, Inc. | 1987 | — |
| −1 | K982462 | Fiber Optic Endoillumination Probe | Microvision, Inc. | 1998 | — |
| 0 (this device) | K050807 | 20G Sma Laser Fiber, Model LF100 | Ophthalmed, LLC | 2005 | — |
| +1 | K121187 | Katalyst Laser Probes, Katalyst Illuminated Laser Probes | Katalyst Surgical, LLC | 2012 | — |
| +1 | K142830 | Ophthalmed Bending Laser Probes | Ophthalmed, LLC | 2015 | — |
| +2 | K191846 | MAXReach Laser Probe | Vortex Surgical, Inc. | 2019 | — |
| +3 | K220263 | Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex… | Vortex Surgical, Inc. | 2022 | 3 |
| +2 | K182646 | Vitreq disposable laser probes, light fibers and Chandelier | VitreQ BV | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 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? (3)
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 1…spiration and cutting 10-Substantial Equivalency is claimed against the following device: 20g and 25g SMA Laser Fibers, Model LF20 and LF25 from OPHTHALMED LLC (5 10k #K021696), as well as 510k #K982462 and K946135. 11-Description of the Device: This device consists of the following parts already conn… | 2002 |
| * | K982462 | Fiber Optic Endoillumination ProbeSummary page 1…ubstantial Equivalency is claimed against the following device: 20g and 25g SMA Laser Fibers, Model LF20 and LF25 from OPHTHALMED LLC (5 10k #K021696), as well as 510k #K982462 and K946135. 11-Description of the Device: This device consists of the following parts already connected to each other: - Hand… | 1998 |
| * | K946135 | Infinitech Aspirating Laser ProbeSummary page 1…quivalency is claimed against the following device: 20g and 25g SMA Laser Fibers, Model LF20 and LF25 from OPHTHALMED LLC (5 10k #K021696), as well as 510k #K982462 and K946135. 11-Description of the Device: This device consists of the following parts already connected to each other: - Handpiece with a… | 1995 |
What descends from it? (6)
2 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K121187 (Katalyst Surgical, LLC, 2012) has gone furthest, with 5 descendants 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.
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?
For use to perform endo-ocular laser photocoaguation treatments, with illumination, aspiration and back-wash during surgical interventions. The operating wavelength is 500nm to 1,100nm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050807: 20G Sma Laser Fiber, Model LF100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050807
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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