510(k) · Cleared
Recalled · 2007Zyoptix XP Epi Separator System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HNO Keratome, Ac-Powered
Cleared on Sep 6, 2006 as substantially equivalent to K040204 (Bausch & Lomb, Inc., 2004) after a 13-day review. Its family tree reaches back 4 generations to 1991. It has been recalled once.
- Decided
- Sep 6, 2006
- Review
- 13 days
- Class
- Class I
- Product code
- HNO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913697 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 3 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 2 generations backK021640 Hansatome Excellus MicrokeratomeBausch & Lomb, Inc. · 2002
- 1 generation backK040204 Zyoptix XP MicrokeratomeBausch & Lomb, Inc. · 2004 · Recalled
- This deviceK062465 Zyoptix XP Epi Separator SystemBausch & Lomb, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −3 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −2 | K021640 | Hansatome Excellus Microkeratome | Bausch & Lomb, Inc. | 2002 | — |
| −1 | K040204 | Zyoptix XP Microkeratome | Bausch & Lomb, Inc. | 2004 | 4 |
| 0 (this device) | K062465 | Zyoptix XP Epi Separator System | Bausch & Lomb, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K040204 | Zyoptix XP MicrokeratomeSummary page 1…HNO Proprietary Name: Zyoptix XP Epi Separator System 3. Predicate Device Zyoptix XP Microkeratome K040204 4. Description of Device The Epi Separator System is designed exclusively for use with the Zyoptix XP Micro… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2007 | Not classified | Z-1021-2007 | Other | Reports have been received of stromal incursions after use of the product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 1 other device also cites its predicate K040204.
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 Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.
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/K062465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062465: Zyoptix XP Epi Separator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062465
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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