510(k) · Cleared
ClearedSynergetics Directional Endoocular Laser Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergetics, Inc. · HQB Photocoagulator And Accessories
Cleared on Apr 23, 2012 as substantially equivalent to K954307 (Gamp & Assoc., 1995) after a 115-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Apr 23, 2012
- Review
- 115 days
- Class
- Class II
- Product code
- HQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954307 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK954307 Gamp & Assoc. Disposable Endoocular Laser ProbeGamp & Assoc. · 1995
- This deviceK113857 Synergetics Directional Endoocular Laser ProbeSynergetics, Inc. · 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
Most influential descendants
Showing 3 of 3 · See all- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954307 | Gamp & Assoc. Disposable Endoocular Laser Probe | Gamp & Assoc. | 1995 | — |
| 0 (this device) | K113857 | Synergetics Directional Endoocular Laser Probe | Synergetics, Inc. | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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 HQB? 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 HQB device
- #1 K220263 Vortex Surgical Laser Probes, Vortex Surgical…score 3.8 · 6 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K954307 | Gamp & Assoc. Disposable Endoocular Laser ProbeSummary page 1…Ophthalmic Predicate Device: Gamp and Associates Disposable Endoocular Laser Probe, K(954307 Device Description: The SynergeticsTMf Disposable Directional Endo Ocular Laser Probe is a sterile single use ophthialmic laser… | 1995 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142830 | Ophthalmed Bending Laser Probes | 2015 | 2 |
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?
How does its category compare?
All HQB devicesHQB Photocoagulator And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HQB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQB
221in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQB
7in 2025
MAUDE reports naming product code HQB, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 57 | 0 | 3 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 3 | 221 | 28 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 2 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synergetics Directional Endo Ocular Laser Probe provides a
mean for delivering endophotocoagulation during vitrectomy
surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113857 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113857: Synergetics Directional Endoocular 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/K113857
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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