510(k) · Cleared

Cleared

Cataract Liquefracture Device

K980292510(k) TraditionalCleared May 19, 1998113-day reviewClass II21 CFR 886.4670

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

Alcon Laboratories · MUS Fluidic, Phacoemulsification/Phacofragmentation

Cleared on May 19, 1998 as substantially equivalent to K911808 (Alcon Laboratories, 1991) and 1 other predicate after a 113-day review. Its family tree reaches back 1 generation to 1990. 59 later devices descend from it.

Decided: May 19, 1998
Review: 113 days
Class: Class II
Product code: MUS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K902798 (1990). 2 ancestors in all. 59 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK902798 Automated Hydrosonics (TM)Alcon Surgical, Inc. · 1990
This deviceK980292 Cataract Liquefracture DeviceAlcon Laboratories · 1998
Descendant · cites it directly · 50 of its ownK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
Descendant · 2 generations on · 36 of its ownK063583 Alcon Vision SystemAlcon · 2008 · Recalled
Descendant · 2 generations on · 24 of its ownK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
Descendant · 2 generations on · 22 of its ownK082845 Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009
Descendant · 3 generations on · 22 of its ownK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2002high 7 (2017) · low 0 (2004)2026

Most influential descendants

Showing 5 of 59 · See all

K021566InfinitiAlcon Laboratories, Inc. · 2002 · cites it directly50descendants
K063583Alcon Vision SystemAlcon · 2008 · 2 generations on36descendants
K063331Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · 2 generations on24descendants
K082845Infiniti Vision System with Ozil IPAlcon Research, Ltd. · 2009 · 2 generations on22descendants
K082473Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · 3 generations on22descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902798	Automated Hydrosonics (TM)	Alcon Surgical, Inc.	1990	—
0 (this device)	K980292	Cataract Liquefracture Device	Alcon Laboratories	1998	—
+1	K021566	Infiniti	Alcon Laboratories, Inc.	2002	3
+2	K063583	Alcon Vision System	Alcon	2008	11
+2	K063331	Bausch & Lomb NGX Microsurgical System	Bausch & Lomb, Inc.	2006	12
+2	K082845	Infiniti Vision System with Ozil IP	Alcon Research, Ltd.	2009	—
+3	K082473	Bausch & Lomb Stellaris Microsurgical System	Bausch & Lomb, Inc.	2009	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2005	1	0
2006	1	0
2008	2	0
2009	4	0
2010	5	0
2011	4	0
2012	6	0
2013	2	0
2014	5	0
2015	4	0
2017	7	0
2019	2	0
2020	2	0
2021	1	0
2022	3	0
2023	1	0
2024	5	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K980292, 1990–2026Source: 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 MUS? 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? (2)

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
*	K911808	Gemini Ophthalmic Surgery System Summary page 2 …=== KGFoRT L 1. Predicate Device The legally marketed device(s) to which we are claiming equivalence to are: Phacoemuilsification function associated with Alcon’s: . o K911808, Gemini Ophthalmic Surgery System (being marketed as the Series 20,000 Legacy® (STTL)). Automated HydroSonics® function: K90279…	Alcon Laboratories	1991	2
*	K902798	Automated Hydrosonics (TM) Summary page 2 …function associated with Alcon’s: . o K911808, Gemini Ophthalmic Surgery System (being marketed as the Series 20,000 Legacy® (STTL)). Automated HydroSonics® function: K902798 2. Device Descrption The Liquefracture device is designed to assist ophthalmic surgeons in the removal of cataractous lenses (c…	Alcon Surgical, Inc.	1990	—

Also cleared against K911808: 13 other devices →

What descends from it? (59)

See all 59

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

Number	Device	Applicant	Decided	Descendants
K021566	Infiniti	Alcon Laboratories, Inc.	2002	50
K093210	Aqualase Capsule Wash Tip	Alcon Manufacturing, Ltd.	2010	9
K030179	Medisiss Phacoemulsification Tips/Needles	Surgical Instruments Service and Savings, Inc.	2003	4
K092066	Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…	Andrew Technologies, LLC	2010	2

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?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K021566 (Alcon Laboratories, Inc., 2002) has gone furthest, with 50 descendants of its own.
13 other devices also cite its predicate K911808.

How does its category compare?

All MUS devices

MUS Fluidic, Phacoemulsification/Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUS

FDA has decided no MUS device since 2007.

Median 510(k) review, days · MUS

Too few MUS 510(k)s in any year since 2007 to give a median.

Recalls per year · MUS

No recall names MUS since 2007.

Adverse event reports per year · MUS

No MAUDE report names MUS since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract

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/K980292 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980292: Cataract Liquefracture Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980292

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