510(k) · Cleared

Cleared

Ultrashaper Keratome

K990227510(k) TraditionalCleared Jan 31, 2000371-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

Lasersight Technologies, Inc. · HNO Keratome, Ac-Powered

Cleared on Jan 31, 2000 as substantially equivalent to K941550 (Chiron Vision Corp., 1994) and 2 other predicates after a 371-day review. Its family tree reaches back 1 generation to 1986. 59 later devices descend from it.

Decided: Jan 31, 2000
Review: 371 days
Class: Class I
Product code: HNO
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K860001 (1986). 3 ancestors in all. 59 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK860001 Barraquer-Krumeich Refractive SetAmerican Medical Optics · 1986
This deviceK990227 Ultrashaper KeratomeLasersight Technologies, Inc. · 2000
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 59 descendants. See all descendants

Descendants cleared per year

2004high 8 (2012) · low 0 (2005)2026

Most influential descendants

Showing 5 of 59 · 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	K860001	Barraquer-Krumeich Refractive Set	American Medical Optics	1986	—
0 (this device)	K990227	Ultrashaper Keratome	Lasersight Technologies, Inc.	2000	—
+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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2008	2	0
2009	2	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 K990227, 1986–2025Source: 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? (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	Applicant	Decided	Recalls
*	K941550	Automatic Corneal Shaper Surgical Instrument Summary page 1 …o the following predicate devices: e Automatic Corneal Shaper, manufactured and distributed by Chiron Vision Corporation, 9342 Jeronimo Road, Irvine, CA [cleared under K941550]. * Steinway-Barraquer In-Situ Microkeratome Set, manufactured and distributed by Steinway Instrument Company, Inc., San Diego,…	Chiron Vision Corp.	1994	—
*	K860001	Barraquer-Krumeich Refractive Set Summary page 1 …distributed by Steinway Instrument Company, Inc., San Diego, CA. This device is identical to the Allergan Medical Optics Barraquer-Krumeich Refractive Set [cleared under K860001]. . Micro Refractive System Model 1000, manufactured and distributed by Micro Precision Instrument Company, 2323 N. Central Aven…	American Medical Optics	1986	—
*	K903912	Keratome Summary page 1 …. Micro Refractive System Model 1000, manufactured and distributed by Micro Precision Instrument Company, 2323 N. Central Avenue, Suite 2105, Phoenix, AZ [cleared under K903912]. Description of Device: Device Description: The UltraShaper™ System consists of the following components: (a) cutting head, (b…	Micro Precision Instrument Co.	1990	—

Also cleared against K941550: 4 other devices →

What descends from it? (59)

See all 59

1 later device cites 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

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?

None of the 3 ancestors has a recall.
Of its descendants, K032910 (Schwind Eye-Tech-Solutions GmbH & Co. KG, 2004) has gone furthest, with 58 descendants of its own.
4 other devices also cite its predicate K941550.

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 UltraShaper™ System is an AC-powered device that is intended to shave a partial

lamella section 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/K990227 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990227: Ultrashaper Keratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990227

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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