510(k) · Cleared
ClearedModification to Ciba Vision Centurion Ses Spikeratome
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 Oct 20, 2003 as substantially equivalent to K031735 (Ciba Vision Corporation, 2003) after a 26-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it.
- Decided
- Oct 20, 2003
- Review
- 26 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960261 (1996). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK960261 Pallikaris BrushAlcon Laboratories, Inc. · 1996
- 2 generations backK962989 Amoils Epithelial ScrubberS. Percy Amoils · 1997
- 1 generation backK031735 Centurion Ses EpikeratomeCiba Vision Corporation · 2003
- This deviceK032978 Modification to Ciba Vision Centurion Ses SpikeratomeCiba Vision Corporation · 2003
- Descendant · cites it directly · 3 of its ownK041206 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 · 2 generations on · 0 of its ownK072102 Epivision SL SystemGebauer Medizintechnik GmbH · 2009
- Descendant · cites it directly · 0 of its ownK042810 Centurion Ses EpikeratomeNorwood Abbey, Ltd. · 2004
Most influential descendants
Showing 5 of 5 · See all- K041206Epitome SystemGebauer Medizintechnik GmbH · 2004 · cites it directly3descendants
- K043183EPI-KMoria SA · 2005 · cites it directly1descendant
- K172994EPI K ConsoleMoria SA · 2017 · 2 generations on0descendants
- K072102Epivision SL SystemGebauer Medizintechnik GmbH · 2009 · 2 generations on0descendants
- K042810Centurion Ses EpikeratomeNorwood Abbey, Ltd. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960261 | Pallikaris Brush | Alcon Laboratories, Inc. | 1996 | — |
| −2 | K962989 | Amoils Epithelial Scrubber | S. Percy Amoils | 1997 | — |
| −1 | K031735 | Centurion Ses Epikeratome | Ciba Vision Corporation | 2003 | — |
| 0 (this device) | K032978 | Modification to Ciba Vision Centurion Ses Spikeratome | Ciba Vision Corporation | 2003 | — |
| +1 | K041206 | Epitome System | Gebauer Medizintechnik GmbH | 2004 | — |
| +1 | K043183 | EPI-K | Moria SA | 2005 | — |
| +2 | K172994 | EPI K Console | Moria SA | 2017 | — |
| +2 | K072102 | Epivision SL System | Gebauer Medizintechnik GmbH | 2009 | — |
| +1 | K042810 | Centurion Ses Epikeratome | Norwood Abbey, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K031735 | Centurion Ses EpikeratomeSummary page 1…AND PRODUCT CODE SUBSTANTIAL EQUIVALENCE: The modified Centurion SES Epikeratome is substantially equivalent to the Centurion SES Epikeratome cleared under K031735. The modifications made to the device include a separate dedicated handpiece for the epikeratome function. Minor design modificat… | 2003 |
What descends from it? (5)
3 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K041206 (Gebauer Medizintechnik GmbH, 2004) has gone furthest, with 3 descendants of its own.
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 LASIK or other treatment requiring initial lamellar resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032978: Modification to Ciba Vision Centurion Ses Spikeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032978
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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