510(k) · Cleared
ClearedD.O.R.C. Hexon Illumination System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dutch Ophthalmic USA, Inc. · MPA Endoilluminator
Cleared on Nov 25, 1997 as substantially equivalent to K963417 (Escalon Trek Medical, 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.
- Decided
- Nov 25, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- MPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963417 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963417 Vitlite (TR7700)Escalon Trek Medical · 1996
- This deviceK973229 D.O.R.C. Hexon Illumination SystemDutch Ophthalmic USA, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK062895 Xenon Brightstar Illumination System, Model 1266.XiiiDutch Ophthalmic Research Center International BV · 2006
- Descendant · cites it directly · 0 of its ownK062259 Iscience Surgical Fiberoptic Illuminator, Model FI - 100Iscience Surgical · 2006
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 |
|---|---|---|---|---|---|
| −1 | K963417 | Vitlite (TR7700) | Escalon Trek Medical | 1996 | — |
| 0 (this device) | K973229 | D.O.R.C. Hexon Illumination System | Dutch Ophthalmic USA, Inc. | 1997 | — |
| +1 | K062895 | Xenon Brightstar Illumination System, Model 1266.Xiii | Dutch Ophthalmic Research Center International BV | 2006 | — |
| +1 | K062259 | Iscience Surgical Fiberoptic Illuminator, Model FI - 100 | Iscience Surgical | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 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 |
|---|---|---|---|
| * | K963417 | Vitlite (TR7700)Summary page 1…nation Systemn Common/Usual Name: Endoillumination System Classification Name: Ophthalmic Light Source 3. PREDICATE DEVICE/S Grieshaber Light Sowvce Esculon VitLite I (K963417) 4. DEVICE DESCRIPTION The D.O.R.C. HEXON Illumination System consists of the Illumination Unit and accessories. The Illuminati… | 1996 |
| * | — | Grieshaber Light Source Named without a submission number |
What descends from it? (2)
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?
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 D.O.R.C. Hexon Illumination System is indicated for intraocular illumination in vitreoretinal surgery.
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/K973229 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973229: D.O.R.C. Hexon Illumination System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973229
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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