510(k) · Cleared

Cleared

Hansatome Microkeratome

K972808510(k) TraditionalCleared Oct 24, 199788-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

Chiron Vision Corp. · HNO Keratome, Ac-Powered

Cleared on Oct 24, 1997 as substantially equivalent to K913697 (Hansa Research & Development, Inc., 1991) after an 88-day review. Its family tree reaches back 1 generation to 1991. 80 later devices descend from it.

Decided: Oct 24, 1997
Review: 88 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K913697 (1991). 80 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
This deviceK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
Descendant · cites it directly · 66 of its ownK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
Descendant · 2 generations on · 65 of its ownK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
Descendant · cites it directly · 63 of its ownK981741 Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998
Descendant · 3 generations on · 61 of its ownK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
Descendant · cites it directly · 61 of its ownK021640 Hansatome Excellus MicrokeratomeBausch & Lomb, Inc. · 2002

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

1998high 8 (2012) · low 0 (2001)2026

Most influential descendants

Showing 5 of 80 · See all

K993153Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · cites it directly66descendants
K013941Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · 2 generations on65descendants
K981741Carriazo Barraquer MicrokeratomeMoria, Inc. · 1998 · cites it directly63descendants
K031960Intralase FS LaserIntra Lase Corp. · 2003 · 3 generations on61descendants
K021640Hansatome Excellus MicrokeratomeBausch & Lomb, Inc. · 2002 · cites it directly61descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913697	Automatic Corneal Shaper	Hansa Research & Development, Inc.	1991	—
0 (this device)	K972808	Hansatome Microkeratome	Chiron Vision Corp.	1997	—
+1	K993153	Intralase 600C Laser Keratome	Intra Lase Corp.	1999	1
+2	K013941	Pulsion FS Laser Keratome	Intra Lase Corp.	2002	1
+1	K981741	Carriazo Barraquer Microkeratome	Moria, Inc.	1998	—
+3	K031960	Intralase FS Laser	Intra Lase Corp.	2003	3
+1	K021640	Hansatome Excellus Microkeratome	Bausch & Lomb, Inc.	2002	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2000	1	0
2002	4	0
2003	3	0
2004	4	0
2005	1	0
2006	4	0
2007	1	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 K972808, 1991–2025Source: 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

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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
*	K913697	Automatic Corneal Shaper Summary page 1 …lly marketed device or devices to which substantial equivalence is being claimed: Company: Hansa Research & Development, Inc. Device: Automatic Corneal Shaper 510(k) : K913697 128 July 25, 1997 Hansa Research & Development, Inc. Premarket Notification HANSATOME™ Microkeratome Date Cle…	Hansa Research & Development, Inc.	1991	—

Also cleared against K913697: 6 other devices →

What descends from it? (80)

See all 80

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

Number	Device	Applicant	Decided	Descendants
K993153	Intralase 600C Laser Keratome	Intra Lase Corp.	1999	66
K981741	Carriazo Barraquer Microkeratome	Moria, Inc.	1998	63
K021640	Hansatome Excellus Microkeratome	Bausch & Lomb, Inc.	2002	61
K032910	Carriazo Pendular	Schwind Eye-Tech-Solutions GmbH & Co. KG	2004	58
K993190	Advanced Computer Controlled Microkeratome-Accm, Model Surgical Instrument Systems (Sis)	Surgical Instrument Systems (Sis), Ltd.	2000	2
K990900	Microkeratome, Model MK-2000	Nidek, Inc.	1999	2
K020122	MB 102 Millennium Blades	Millennium Biomedical, Inc.	2002	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, K993153 (Intra Lase Corp., 1999) has gone furthest, with 66 descendants of its own.
6 other devices also cite its predicate K913697.

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 Hansatome™ microkeratome is a precision-manufactured instrument indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the comea.

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/K972808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972808: 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/K972808

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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