510(k) · Cleared

Cleared

Vistitome 20-10 Microkeratome

K014000510(k) TraditionalCleared Mar 11, 200297-day reviewClass I21 CFR 886.4370

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biovision AG · HNO Keratome, Ac-Powered

Cleared on Mar 11, 2002 as substantially equivalent to K010260 (Bausch & Lomb, Inc., 2001) after a 97-day review. Its family tree reaches back 1 generation to 2001. 61 later devices descend from it.

Decided: Mar 11, 2002
Review: 97 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010260 (2001). 61 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK010260 Hansatome MicrokeratomeBausch & Lomb, Inc. · 2001
This deviceK014000 Vistitome 20-10 MicrokeratomeBiovision AG · 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

2004high 8 (2012) · low 0 (2005)2026

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
−1	K010260	Hansatome Microkeratome	Bausch & Lomb, Inc.	2001	—
0 (this device)	K014000	Vistitome 20-10 Microkeratome	Biovision AG	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2008	2	0
2009	3	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

FIG. 1 — Lineage of K014000, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K010260	Hansatome Microkeratome Summary page 2 …he following predicate device (predicate device information can be found in Section 10): Predicate 510(K) Owner 510(k) No. Date Cleared Device Hansatome Bausch & Lomb K010260 April 27, 2001 Microkeratome \| Surgical 6. TECHNOLOGICAL CHARACTERISTICS A comparison of the technological characteristics of t…	Bausch & Lomb, Inc.	2001	—

Also cleared against K010260: 3 other devices →

What descends from it? (61)

See all 61

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K032910	Carriazo Pendular	Schwind Eye-Tech-Solutions GmbH & Co. KG	2004	58
K042083	Modification to Visitome 20-10 Microkeratome	Biovision AG	2004	1
K072102	Epivision SL System	Gebauer Medizintechnik GmbH	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?

Its one ancestor has no recall.
Of its descendants, K032910 (Schwind Eye-Tech-Solutions GmbH & Co. KG, 2004) has gone furthest, with 58 descendants of its own.
3 other devices also cite its predicate K010260.

How does its category compare?

All HNO devices

HNO Keratome, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HNO

1in 2018

2007high 1 (2008) · low 0 (2007)2026

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

2007high 4 (2011) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HNO

7in 2024

2007high 2,265 (2018) · low 0 (2025)2025

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 indicated for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the 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/K014000 · printed Nov 4, 2026

Cite this page

510(k) Report. “K014000: Vistitome 20-10 Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014000

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026