510(k) · Cleared

Cleared

Lensx 550 Laser System

K082947510(k) TraditionalCleared Aug 14, 2009316-day reviewClass II21 CFR 886.4390

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

Lensx Lasers, Inc. · OOE Ophthalmic Femtosecond Laser

Cleared on Aug 14, 2009 as substantially equivalent to K001498 (Medisurg, Ltd., 2000) and 13 other predicates after a 316-day review. Its family tree reaches back 8 generations to 1991. 51 later devices descend from it.

Decided: Aug 14, 2009
Review: 316 days
Class: Class II
Product code: OOE
Recalls: None
Predicates: 14

Its longest line of descent runs back 8 generations to K913697 (1991). 48 ancestors in all, the oldest K860001 (1986). 51 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 8 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
7 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
6 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
5 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
4 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
3 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
2 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
1 generation backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
This deviceK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Descendant · cites it directly · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
Descendant · cites it directly · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Descendant · cites it directly · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
Descendant · 2 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
Descendant · cites it directly · 18 of its ownK090633 Lensar Laser SystemLensar, Inc. · 2010

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2009high 7 (2012) · low 0 (2019)2026

Most influential descendants

Showing 5 of 51 · See all

K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · cites it directly47descendants
K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · cites it directly31descendants
K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · cites it directly30descendants
K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 2 generations on19descendants
K090633Lensar Laser SystemLensar, Inc. · 2010 · cites it directly18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K913697	Automatic Corneal Shaper	Hansa Research & Development, Inc.	1991	—
−7	K972808	Hansatome Microkeratome	Chiron Vision Corp.	1997	—
−6	K993153	Intralase 600C Laser Keratome	Intra Lase Corp.	1999	1
−5	K013941	Pulsion FS Laser Keratome	Intra Lase Corp.	2002	1
−4	K031960	Intralase FS Laser	Intra Lase Corp.	2003	3
−3	K060372	Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3	Intra Lase Corp.	2006	—
−2	K063682	Intralase Fusion Laser	Intra Lase Corp.	2007	—
−1	K073404	Ifs Laser System	Intra Lase Corp.	2008	—
0 (this device)	K082947	Lensx 550 Laser System	Lensx Lasers, Inc.	2009	—
+1	K094052	Lensx 550 Laser System. Model 550	Lensx Lasers, Inc.	2010	—
+1	K092647	Lensx 550 Laser System	Lensx Lasers, Inc.	2009	—
+1	K101626	Lensx Laser System	Lensx Lasers, Inc.	2010	—
+2	K113151	Ifs Laser System	Abbott Medical Optics, Inc.	2012	—
+1	K090633	Lensar Laser System	Lensar, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1987	1	0
1989	1	0
1990	1	0
1994	2	0
1995	1	0
1996	4	0
1997	6	0
1998	7	0
1999	1	0
2000	3	0
2001	3	0
2002	3	0
2004	3	0
2005	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	3	0
2011	4	0
2012	7	0
2013	2	0
2014	4	0
2015	6	0
2016	2	0
2017	6	0
2018	6	0
2020	2	0
2021	1	0
2022	3	0
2023	2	0
2025	2	0

FIG. 1 — Lineage of K082947, 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 OOE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OOE device

#1 K243896 LenSx Laser System (8065998162)score 16.7 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (14)

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
*	K001498	The Fugo Blade Summary page 2 …947- SUMMARY OF SAFETY AND EFFECTIVENESS PREDICATE DEVICES 510(K) # TRADE NAME MANUFACTURER K001498 The Fugo Blade Medisurg Research and…	Medisurg, Ltd.	2000	1
*	K040005	Profile 2000/3000 Laser System Summary page 2 …surg Research and Management Corp. Profile 3000 laser System and K040005 Delivery Devices and Sciton, Inc. Accessories…	Sciton, Inc	2004	—
*	K052806	Burane Summary page 2 …le 3000 laser System and K040005 Delivery Devices and Sciton, Inc. Accessories K052806 K052806 Laser System Burane Laser…	Wavelight Laser Technologie AG	2005	—
*	K021548	Fotona Dualis ND:Yag/ER:Yag Laser System Summary page 2 …WaveLight Laser AG K02 1548 Fotona Dualis Nd:YAG/Er:YAG Laser System K033354 FEMTEC Laser M…	Fotona D.D.	2002	—
*	K033354	Femtec Laser Microkeratome Summary page 2 …AG K02 1548 Fotona Dualis Nd:YAG/Er:YAG Laser System K033354 FEMTEC Laser Microkeratome 20/10 Perfect Vision Optische…	20/10 Perfect Vision Optische Gerate GmbH	2004	—
*	K993153	Intralase 600C Laser Keratome Summary page 2 …Gerat VMBH Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K06…	Intra Lase Corp.	1999	1
*	K001211	Modification to Intralase 600C Laser Keratome Summary page 2 …Gerat VMBH Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K063682, and…	Intra Lase Corp.	2000	1
*	K002890	Intralase 600C Laser Keratome Summary page 2 …Gerat VMBH Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K063682, and K07…	Intra Lase Corp.	2001	1
*	K013941	Pulsion FS Laser Keratome Summary page 2 …Gerat VMBH Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K063682, and K073404…	Intra Lase Corp.	2002	1
*	K031960	Intralase FS Laser Summary page 2 …Gerat VMBH Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K063682, and K073404 DEVICE DE…	Intra Lase Corp.	2003	3
*	K041893	Intralase FS Laser Summary page 2 …Gerat VMBH Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K063682, and K073404 DEVICE DESCRIPTION…	Intra Lase Corp.	2005	—
*	K060372	Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 Summary page 2 …Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K063682, and K073404 DEVICE DESCRIPTION The LenSx 550 Laser is an ophthalmic surgical laser intended for use in pa…	Intra Lase Corp.	2006	—
*	K063682	Intralase Fusion Laser Summary page 2 …Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K063682, and K073404 DEVICE DESCRIPTION The LenSx 550 Laser is an ophthalmic surgical laser intended for use in patients…	Intra Lase Corp.	2007	—
*	K073404	Ifs Laser System Summary page 2 …Gerate GMBH K993153, K001211, K002890, K013941, K031960, K041893, IntraLase FS Lasers IntraLase Corp. K060372, K063682, and K073404 DEVICE DESCRIPTION The LenSx 550 Laser is an ophthalmic surgical laser intended for use in patients requiring an anteri…	Intra Lase Corp.	2008	—

Also cleared against K001498: 4 other devices →

What descends from it? (51)

See all 51

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

Number	Device	Applicant	Decided	Descendants
K094052	Lensx 550 Laser System. Model 550	Lensx Lasers, Inc.	2010	47
K092647	Lensx 550 Laser System	Lensx Lasers, Inc.	2009	31
K101626	Lensx Laser System	Lensx Lasers, Inc.	2010	30
K090633	Lensar Laser System	Lensar, Inc.	2010	18
K102727	Lensar Laser System for Anterior Capsulotomy	Lensar, Inc.	2011	12
K110427	Femtec Laser System for Capsulotomy	Technolas Perfect Vision GmbH	2011	8
K112098	TBD	Lensar, Inc.	2011	7

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?

The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
7 of the 48 ancestors have a recall of any class.
Of its descendants, K094052 (Lensx Lasers, Inc., 2010) has gone furthest, with 47 descendants of its own.
4 other devices also cite its predicate K001498.

How does its category compare?

All OOE devices

OOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · OOE

2in 2025

2007high 6 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OOE

129in 2022

2007high 151 (2015) · low 81 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OOE

1in 2021

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · OOE

438in 2025

2007high 689 (2015) · low 0 (2007)2025

MAUDE reports naming product code OOE, 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	—	0	0
2008	0	—	0	0
2009	2	—	0	0
2010	3	131	0	0
2011	4	132	0	10
2012	4	138	0	74
2013	2	—	1	164
2014	4	133	0	264
2015	5	151	0	689
2016	2	—	0	482
2017	6	81	0	483
2018	5	99	1	434
2019	0	—	0	311
2020	2	—	0	199
2021	1	—	1	328
2022	3	129	0	204
2023	2	—	0	231
2024	0	—	0	325
2025	2	—	0	438
2026	0	—	0	—

What is it indicated for?

The LenSx 550 Laser System is indicated for anterior capsulotomy during cataract surgery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082947 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082947: Lensx 550 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082947

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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