510(k) · Cleared

Cleared

Hansatome Microkeratome

K010260510(k) TraditionalCleared Apr 27, 200188-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

Bausch & Lomb, Inc. · HNO Keratome, Ac-Powered

Cleared on Apr 27, 2001 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 67 later devices descend from it.

Decided: Apr 27, 2001
Review: 88 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 0

67 later devices descend from it, 4 citing it directly.

This deviceK010260 Hansatome MicrokeratomeBausch & Lomb, Inc. · 2001
Descendant · cites it directly · 61 of its ownK021640 Hansatome Excellus MicrokeratomeBausch & Lomb, Inc. · 2002
Descendant · cites it directly · 61 of its ownK014000 Vistitome 20-10 MicrokeratomeBiovision AG · 2002
Descendant · 2 generations on · 58 of its ownK032910 Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004
Descendant · 3 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
Descendant · cites it directly · 52 of its ownK033354 Femtec Laser Microkeratome20/10 Perfect Vision Optische Gerate GmbH · 2004

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2002high 8 (2012) · low 0 (2003)2026

Most influential descendants

Showing 5 of 67 · See all

K021640Hansatome Excellus MicrokeratomeBausch & Lomb, Inc. · 2002 · cites it directly61descendants
K014000Vistitome 20-10 MicrokeratomeBiovision AG · 2002 · cites it directly61descendants
K032910Carriazo PendularSchwind Eye-Tech-Solutions GmbH & Co. KG · 2004 · 2 generations on58descendants
K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 3 generations on56descendants
K033354Femtec Laser Microkeratome20/10 Perfect Vision Optische Gerate GmbH · 2004 · cites it directly52descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010260	Hansatome Microkeratome	Bausch & Lomb, Inc.	2001	—
+1	K021640	Hansatome Excellus Microkeratome	Bausch & Lomb, Inc.	2002	—
+1	K014000	Vistitome 20-10 Microkeratome	Biovision AG	2002	—
+2	K032910	Carriazo Pendular	Schwind Eye-Tech-Solutions GmbH & Co. KG	2004	—
+3	K073404	Ifs Laser System	Intra Lase Corp.	2008	—
+1	K033354	Femtec Laser Microkeratome	20/10 Perfect Vision Optische Gerate GmbH	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2004	4	0
2006	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 K010260, 2001–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (67)

See all 67

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

Number	Device	Applicant	Decided	Descendants
K021640	Hansatome Excellus Microkeratome	Bausch & Lomb, Inc.	2002	61
K014000	Vistitome 20-10 Microkeratome	Biovision AG	2002	61
K033354	Femtec Laser Microkeratome	20/10 Perfect Vision Optische Gerate GmbH	2004	52
K062314	Horus Laser Keratome	Carl Zeiss Meditec, AG	2006	15

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?

Of its descendants, K021640 (Bausch & Lomb, Inc., 2002) has gone furthest, with 61 descendants of its own.

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	—

https://510kreport.com/device/K010260 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010260: Hansatome Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010260

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026