510(k) · Cleared
ClearedModification to Visitome 20-10 Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biovision AG · HNO Keratome, Ac-Powered
Cleared on Nov 16, 2004 as substantially equivalent to K014000 (Biovision AG, 2002) and 1 other predicate after a 105-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Nov 16, 2004
- Review
- 105 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K913697 (1991). 8 ancestors in all, the oldest K892058 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 4 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 3 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 2 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 1 generation backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- This deviceK042083 Modification to Visitome 20-10 MicrokeratomeBiovision AG · 2004
- Descendant · cites it directly · 0 of its ownK072102 Epivision SL SystemGebauer Medizintechnik GmbH · 2009
Most influential descendants
Showing 1 of 1 · See all- K072102Epivision SL SystemGebauer Medizintechnik GmbH · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −4 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −3 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −2 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −1 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| 0 (this device) | K042083 | Modification to Visitome 20-10 Microkeratome | Biovision AG | 2004 | — |
| +1 | K072102 | Epivision SL System | Gebauer Medizintechnik GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (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 |
|---|---|---|---|
| * | K014000 | Vistitome 20-10 MicrokeratomeSummary page 2…fectiveness. Predicate Applicant 510(k) No. Date Cleared Device Visitome 20-10 Biovision AG K014000 March 11. 2002 Microkeratome FS Laser Intralase K031960 September… | 2002 |
| * | K031960 | Intralase FS LaserSummary page 2…evice Visitome 20-10 Biovision AG K014000 March 11. 2002 Microkeratome FS Laser Intralase K031960 September 29, 2003 Keratome Corporation 6. TECHNOLOGICAL CHARACTERISTICS The Visit… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072102 | Epivision SL System | 2009 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K072102 (Gebauer Medizintechnik GmbH, 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K014000.
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 VISITOME 20-10 MICROKERATOME is intended 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/K042083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042083: Modification to Visitome 20-10 Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042083
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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