510(k) · Cleared
Recalled · 2008Zyoptix XP Microkeratome
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 Mar 22, 2004 as substantially equivalent to K021640 (Bausch & Lomb, Inc., 2002) after a 53-day review. Its family tree reaches back 3 generations to 1991. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 22, 2004
- Review
- 53 days
- Class
- Class I
- Product code
- HNO
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K913697 (1991). 4 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 2 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 1 generation backK021640 Hansatome Excellus MicrokeratomeBausch & Lomb, Inc. · 2002
- This deviceK040204 Zyoptix XP MicrokeratomeBausch & Lomb, Inc. · 2004
- Descendant · cites it directly · 7 of its ownK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
- Descendant · 2 generations on · 6 of its ownK122386 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013
- Descendant · 2 generations on · 5 of its ownK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- Descendant · 3 generations on · 3 of its ownK141379 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015
- Descendant · 3 generations on · 3 of its ownK140615 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K120426Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012 · cites it directly7descendants
- K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013 · 2 generations on6descendants
- K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · 2 generations on5descendants
- K141379Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2015 · 3 generations on3descendants
- K140615Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −2 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −1 | K021640 | Hansatome Excellus Microkeratome | Bausch & Lomb, Inc. | 2002 | — |
| 0 (this device) | K040204 | Zyoptix XP Microkeratome | Bausch & Lomb, Inc. | 2004 | — |
| +1 | K120426 | Victus Laser Platform | Technolas Perfect Vision GmbH | 2012 | — |
| +2 | K122386 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2013 | — |
| +2 | K132534 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| +3 | K141379 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2015 | — |
| +3 | K140615 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K021640 | Hansatome Excellus MicrokeratomeSummary page 1…me: Keratome Proprietary Name: Zyoptix T M XP Microkeratome 3. PREDICATE DEVICES Hansatome® ExcelluSTM Microkeratome K021640 PAGE 200 510(k) PREMARKET NOTIFICAT… | 2002 |
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2008 | Not classified | Z-0103-2009 | Device Design | The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating. |
| Apr 23, 2008 | Not classified | Z-0104-2009 | Device Design | The plastic tip on the drive shaft may come off the shaft and cause the blade to stop oscillating. |
| Jun 8, 2007 | Not classified | Z-1021-2007 | Other | Reports have been received of stromal incursions after use of the product. |
| Jun 8, 2007 | Not classified | Z-1022-2007 | 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 13 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120426 (Technolas Perfect Vision GmbH, 2012) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K021640.
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 ZyoptixTM XP Microkeratome is a precision-manufactured instrument indicated for use in creating a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040204: Zyoptix XP Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040204
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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