510(k) · Cleared
ClearedSynergetics Synerlight Fiber Optic Lightsource
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synergetics, Inc. · MPA Endoilluminator
Cleared on Jun 9, 1997 after a 275-day review. The FDA summary names its predicate without a number. 40 later devices descend from it.
- Decided
- Jun 9, 1997
- Review
- 275 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 2 citing it directly.
- This deviceK964005 Synergetics Synerlight Fiber Optic LightsourceSynergetics, Inc. · 1997
- Descendant · cites it directly · 38 of its ownK032598 Synergetics Synerlight Fiber Optic LightsourceSynergetics, Inc. · 2003
- Descendant · 2 generations on · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
- Descendant · 3 generations on · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
- Descendant · 3 generations on · 20 of its ownK091777 Alcon UltrachopperAlcon Research, Ltd. · 2009
- Descendant · 3 generations on · 18 of its ownK093305 Enhanced Ultra Vit ProbeAlcon Research, Ltd. · 2010
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K032598Synergetics Synerlight Fiber Optic LightsourceSynergetics, Inc. · 2003 · cites it directly38descendants
- K063583Alcon Vision SystemAlcon · 2008 · 2 generations on36descendants
- K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · 3 generations on22descendants
- K091777Alcon UltrachopperAlcon Research, Ltd. · 2009 · 3 generations on20descendants
- K093305Enhanced Ultra Vit ProbeAlcon Research, Ltd. · 2010 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964005 | Synergetics Synerlight Fiber Optic Lightsource | Synergetics, Inc. | 1997 | — |
| +1 | K032598 | Synergetics Synerlight Fiber Optic Lightsource | Synergetics, Inc. | 2003 | — |
| +2 | K063583 | Alcon Vision System | Alcon | 2008 | 11 |
| +3 | K082845 | Infiniti Vision System with Ozil IP | Alcon Research, Ltd. | 2009 | — |
| +3 | K091777 | Alcon Ultrachopper | Alcon Research, Ltd. | 2009 | — |
| +3 | K093305 | Enhanced Ultra Vit Probe | Alcon Research, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2017 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 MPA? 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 MPA device
- #1 K253468 Nova Eye iTrack™ 250A Canaloplasty…score 12.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | Dutch Ophthalmic, USA Xenon Illumination System catalog number 1266-X Named without a submission number |
What descends from it? (40)
See all 402 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, K032598 (Synergetics, Inc., 2003) has gone furthest, with 38 descendants of its own.
How does its category compare?
All MPA devicesMPA Endoilluminator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MPA
Too few MPA 510(k)s in any year since 2007 to give a median.
Recalls per year · MPA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MPA
11in 2025
MAUDE reports naming product code MPA, 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 | 4 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 39 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 0 | — | 0 | 35 |
| 2013 | 0 | — | 0 | 19 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 2 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 2 | — | 0 | 62 |
| 2025 | 0 | — | 1 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Synergetics Fiber Optic Lightsource is indicated for use during anterior and posterior vitreoretinal surgery te illuminate-the eye.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964005: Synergetics Synerlight Fiber Optic Lightsource.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964005
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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