510(k) · Cleared
ClearedCenturion Ses Epikeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ciba Vision Corporation · HNO Keratome, Ac-Powered
Cleared on Aug 21, 2003 as substantially equivalent to K960261 (Alcon Laboratories, Inc., 1996) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.
- Decided
- Aug 21, 2003
- Review
- 78 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K960261 (1996). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK960261 Pallikaris BrushAlcon Laboratories, Inc. · 1996
- 1 generation backK962989 Amoils Epithelial ScrubberS. Percy Amoils · 1997
- This deviceK031735 Centurion Ses EpikeratomeCiba Vision Corporation · 2003
- Descendant · cites it directly · 5 of its ownK032978 Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003
- Descendant · 2 generations on · 3 of its ownK041206 Epitome SystemGebauer Medizintechnik GmbH · 2004
- Descendant · 2 generations on · 1 of its ownK043183 EPI-KMoria SA · 2005
- Descendant · 3 generations on · 0 of its ownK172994 EPI K ConsoleMoria SA · 2017
- Descendant · 3 generations on · 0 of its ownK072102 Epivision SL SystemGebauer Medizintechnik GmbH · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K032978Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003 · cites it directly5descendants
- K041206Epitome SystemGebauer Medizintechnik GmbH · 2004 · 2 generations on3descendants
- K043183EPI-KMoria SA · 2005 · 2 generations on1descendant
- K172994EPI K ConsoleMoria SA · 2017 · 3 generations on0descendants
- K072102Epivision SL SystemGebauer Medizintechnik GmbH · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960261 | Pallikaris Brush | Alcon Laboratories, Inc. | 1996 | — |
| −1 | K962989 | Amoils Epithelial Scrubber | S. Percy Amoils | 1997 | — |
| 0 (this device) | K031735 | Centurion Ses Epikeratome | Ciba Vision Corporation | 2003 | — |
| +1 | K032978 | Modification to Ciba Vision Centurion Ses Spikeratome | Ciba Vision Corporation | 2003 | — |
| +2 | K041206 | Epitome System | Gebauer Medizintechnik GmbH | 2004 | — |
| +2 | K043183 | EPI-K | Moria SA | 2005 | — |
| +3 | K172994 | EPI K Console | Moria SA | 2017 | — |
| +3 | K072102 | Epivision SL System | Gebauer Medizintechnik GmbH | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K010400 | FDA’s K010400 is Vacuum Assisted Core Biopsy Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K960261 | Pallikaris BrushSummary page 2…ogical characteristics and performance testing demonstrated their equivalence. The Centurion SES is substantially equivalent to the Alcon Pallikaris Brush cleared under K960261 and the Amoils Epithelial Scrubber cleared under K962989 with respect to intended use -to separate the epithelium from the cornea… | 1996 |
| * | K962989 | Amoils Epithelial ScrubberSummary page 2…ed their equivalence. The Centurion SES is substantially equivalent to the Alcon Pallikaris Brush cleared under K960261 and the Amoils Epithelial Scrubber cleared under K962989 with respect to intended use -to separate the epithelium from the cornea Based on the performance testing, it can be concluded t… | 1997 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032978 | Modification to Ciba Vision Centurion Ses Spikeratome | 2003 | 5 |
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 7 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032978 (Ciba Vision Corporation, 2003) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K960261.
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 ClBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASlK or other treatment requiring initial lamellar resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031735: Centurion Ses Epikeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031735
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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