510(k) · Cleared
ClearedEpitome System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebauer Medizintechnik GmbH · HNO Keratome, Ac-Powered
Cleared on Sep 15, 2004 as substantially equivalent to K032978 (Ciba Vision Corporation, 2003) after a 131-day review. Its family tree reaches back 4 generations to 1996. 3 later devices descend from it.
- Decided
- Sep 15, 2004
- Review
- 131 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960261 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK960261 Pallikaris BrushAlcon Laboratories, Inc. · 1996
- 3 generations backK962989 Amoils Epithelial ScrubberS. Percy Amoils · 1997
- 2 generations backK031735 Centurion Ses EpikeratomeCiba Vision Corporation · 2003
- 1 generation backK032978 Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003
- This deviceK041206 Epitome SystemGebauer Medizintechnik GmbH · 2004
- Descendant · cites it directly · 1 of its ownK043183 EPI-KMoria SA · 2005
- Descendant · 2 generations on · 0 of its ownK172994 EPI K ConsoleMoria SA · 2017
- Descendant · cites it directly · 0 of its ownK072102 Epivision SL SystemGebauer Medizintechnik GmbH · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960261 | Pallikaris Brush | Alcon Laboratories, Inc. | 1996 | — |
| −3 | K962989 | Amoils Epithelial Scrubber | S. Percy Amoils | 1997 | — |
| −2 | K031735 | Centurion Ses Epikeratome | Ciba Vision Corporation | 2003 | — |
| −1 | K032978 | Modification to Ciba Vision Centurion Ses Spikeratome | Ciba Vision Corporation | 2003 | — |
| 0 (this device) | K041206 | Epitome System | Gebauer Medizintechnik GmbH | 2004 | — |
| +1 | K043183 | EPI-K | Moria SA | 2005 | — |
| +2 | K172994 | EPI K Console | Moria SA | 2017 | — |
| +1 | K072102 | Epivision SL System | Gebauer Medizintechnik GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 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 HNO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K032978 | Modification to Ciba Vision Centurion Ses SpikeratomeSummary page 2…Device Name 510-K Number Decision Date CIBA Vision CIBA Centurion SESTM K032978 October 20, 2003 Corporation Epikeratome eDevice Description: The EpiTome System is a fully automate… | 2003 |
What descends from it? (3)
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 HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HNO
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HNO
Too few HNO 510(k)s in any year since 2007 to give a median.
Recalls per year · HNO
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HNO
7in 2024
MAUDE reports naming product code HNO, 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 | — | 2 | 32 |
| 2008 | 1 | — | 2 | 31 |
| 2009 | 1 | — | 0 | 85 |
| 2010 | 0 | — | 0 | 84 |
| 2011 | 0 | — | 4 | 90 |
| 2012 | 0 | — | 0 | 100 |
| 2013 | 0 | — | 0 | 353 |
| 2014 | 0 | — | 0 | 452 |
| 2015 | 0 | — | 0 | 966 |
| 2016 | 0 | — | 0 | 1,397 |
| 2017 | 1 | — | 0 | 2,112 |
| 2018 | 1 | — | 0 | 2,265 |
| 2019 | 0 | — | 0 | 816 |
| 2020 | 0 | — | 0 | 405 |
| 2021 | 0 | — | 0 | 72 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The epiTome System is indicated for the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041206: Epitome System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041206
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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