510(k) · Cleared
ClearedIscience Surgical Fiberoptic Illuminator, Model FI - 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iscience Surgical · MPA Endoilluminator
Cleared on Aug 15, 2006 as substantially equivalent to K964005 (Synergetics, Inc., 1997) and 1 other predicate after an 11-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Aug 15, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K963417 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963417 | Vitlite (TR7700) | Escalon Trek Medical | 1996 | — |
| −1 | K973229 | D.O.R.C. Hexon Illumination System | Dutch Ophthalmic USA, Inc. | 1997 | — |
| 0 (this device) | K062259 | Iscience Surgical Fiberoptic Illuminator, Model FI - 100 | Iscience Surgical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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? (2)
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 |
|---|---|---|---|
| * | K964005 | Synergetics Synerlight Fiber Optic LightsourceSummary page 1…tor Predicate Devices: Device Name 510(k) Number Synergetics Synerlight Fiberoptic K964005 Illuminator HEXON Illumination System… | 1997 |
| * | K973229 | D.O.R.C. Hexon Illumination SystemSummary page 1…nergetics Synerlight Fiberoptic K964005 Illuminator HEXON Illumination System K973229 Description of the Device and Summary of the Technological Characteristics: The iScience Surgical Fiberoptic Illuminator (FI)… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K964005.
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 iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062259: Iscience Surgical Fiberoptic Illuminator, Model FI - 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062259
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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