510(k) · Cleared
ClearedHansatome Excellus 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 Jun 19, 2002 as substantially equivalent to K972808 (Chiron Vision Corp., 1997) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 1991. 61 later devices descend from it.
- Decided
- Jun 19, 2002
- Review
- 30 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913697 (1991). 3 ancestors in all. 61 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 1 generation backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- This deviceK021640 Hansatome Excellus MicrokeratomeBausch & Lomb, Inc. · 2002
- Descendant · cites it directly · 58 of its ownK032910 Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004
- Descendant · 2 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- Descendant · 3 generations on · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 4 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
- Descendant · 4 generations on · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004 · cites it directly58descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 2 generations on56descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 3 generations on51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 4 generations on47descendants
- K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −1 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| 0 (this device) | K021640 | Hansatome Excellus Microkeratome | Bausch & Lomb, Inc. | 2002 | — |
| +1 | K032910 | Carriazo Pendular | Schwind Eye-Tech-Solutions GmbH & Co. KG | 2004 | — |
| +2 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| +3 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +4 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
| +4 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
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 |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | K972808 | Hansatome MicrokeratomeSummary page 2…42 Substantial Eauivalent Basis The HansatomeB ExcellusTMMicrokeratome is substantially equivalent to the Hamatome@Microkeratome (K972808 and KO 10260), see Comparison Martix below. COMPARISON MATRIX SIMILARITIES… | 1997 |
| * | K010260 | Hansatome Microkeratome | 2001 |
What descends from it? (61)
See all 612 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 11 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K032910 (Schwind Eye-Tech-Solutions GmbH & Co. KG, 2004) has gone furthest, with 58 descendants of its own.
- 6 other devices also cite its predicate K972808.
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 Bausch & Lomb Hansatome Excellus Microkeratome is a precision-manufactured instrument indicated for use 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/K021640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021640: Hansatome Excellus Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021640
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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