510(k) · Cleared
ClearedEpivision SL System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gebauer Medizintechnik GmbH · HNO Keratome, Ac-Powered
Cleared on Jan 16, 2009 as substantially equivalent to K041206 (Gebauer Medizintechnik GmbH, 2004) and 2 other predicates after a 535-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Jan 16, 2009
- Review
- 535 days
- Class
- Class I
- Product code
- HNO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K913697 (1991). 14 ancestors in all, the oldest K892058 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 5 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 4 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 3 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 2 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 1 generation backK042083 Modification to Visitome 20-10 MicrokeratomeBiovision AG · 2004
- This deviceK072102 Epivision SL SystemGebauer Medizintechnik GmbH · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −5 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −4 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −3 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −2 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −1 | K042083 | Modification to Visitome 20-10 Microkeratome | Biovision AG | 2004 | — |
| 0 (this device) | K072102 | Epivision SL System | Gebauer Medizintechnik GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 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? (3)
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 |
|---|---|---|---|
| * | K041206 | Epitome SystemSummary page 1…510-K Decision Manufacturer Device Name number Date Gebauer EpiTome K041206 09/15/2004 Medizintechnik System and Lasitome GmbH System Keratome… | 2004 |
| * | K014000 | Vistitome 20-10 MicrokeratomeSummary page 1…System Keratome AC powered *Now EpiVision System BioVision Visitome 20-10 K014000 3/11/2002 Microkeratome & &… | 2002 |
| * | K042083 | Modification to Visitome 20-10 MicrokeratomeSummary page 1…K014000 3/11/2002 Microkeratome & & K042083 11/16/2004 *The name was changed from EpiTome to EpiVision System and LasiTome System on 06/10/2005… | 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)
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 18 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 14 ancestors have a recall of any class.
- 1 other device also cites its predicate K041206.
How does its category compare?
All HNO devicesHNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 EpiVision™ SL System is indicated for 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 treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072102: Epivision SL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072102
Report an extraction error
Are you the manufacturer?
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