510(k) Report

510(k) · Cleared

Cleared

Lensx 550 Laser System

K092647510(k) TraditionalCleared Dec 11, 2009106-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 Dec 11, 2009 as substantially equivalent to K082947 (Lensx Lasers, Inc., 2009) and 5 other predicates after a 106-day review. Its family tree reaches back 9 generations to 1991. 31 later devices descend from it.

Decided
Dec 11, 2009
Review
106 days
Class
Class II
Product code
OOE
Recalls
None
Predicates
6

Its longest line of descent runs back 9 generations to K913697 (1991). 50 ancestors in all, the oldest K860001 (1986). 31 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 3 other ancestors2001: 3 other ancestors1998: 7 other ancestors1987: 1 other ancestor1986: 2 other ancestors2004: 3 other ancestors2002: 3 other ancestors2000: 3 other ancestors1999: 1 other ancestor1997: 6 other ancestors1995: 1 other ancestor1989: 1 other ancestor1996: 4 other ancestors1994: 2 other ancestors1990: 1 other ancestor2010: 1 descendant cleared2014: 3 descendants cleared2012: 5 descendants cleared2013: 2 descendants cleared2016: 1 descendant cleared2015: 5 descendants cleared2017: 4 descendants cleared2018: 5 descendants cleared2023: 1 descendant cleared2020: 1 descendant cleared2025: 2 descendants cleared2022: 1 descendant clearedK913697 · Automatic Corneal Shaper · Hansa Research & Development, Inc. · 1991K972808 · Hansatome Microkeratome · Chiron Vision Corp. · 1997K993153 · Intralase 600C Laser Keratome · Intra Lase Corp. · 1999 · recalledK013941 · Pulsion FS Laser Keratome · Intra Lase Corp. · 2002 · recalledK031960 · Intralase FS Laser · Intra Lase Corp. · 2003 · recalledK060372 · Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 · Intra Lase Corp. · 2006K063682 · Intralase Fusion Laser · Intra Lase Corp. · 2007K073404 · Ifs Laser System · Intra Lase Corp. · 2008K082947 · Lensx 550 Laser System · Lensx Lasers, Inc. · 20091990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 8 other ancestors3 generations back: 10 other ancestors4 generations back: 10 other ancestors5 generations back: 6 other ancestors6 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 7 descendants3 generations forward: 9 descendants4 generations forward: 9 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K082947 · Lensx 550 Laser System · Lensx Lasers, Inc. · 2009K073404 · Ifs Laser System · Intra Lase Corp. · 2008K063682 · Intralase Fusion Laser · Intra Lase Corp. · 2007K060372 · Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 · Intra Lase Corp. · 2006K031960 · Intralase FS Laser · Intra Lase Corp. · 2003 · recalledK013941 · Pulsion FS Laser Keratome · Intra Lase Corp. · 2002 · recalledK993153 · Intralase 600C Laser Keratome · Intra Lase Corp. · 1999 · recalledK972808 · Hansatome Microkeratome · Chiron Vision Corp. · 1997K913697 · Automatic Corneal Shaper · Hansa Research & Development, Inc. · 1991−50+5
  1. Root · 9 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
  2. 5 generations between
  3. 3 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
  4. 2 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
  5. 1 generation backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
  6. This deviceK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
  7. Descendant · cites it directly · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
  8. Descendant · 2 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
  9. Descendant · 2 generations on · 12 of its ownK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled
  10. Descendant · 3 generations on · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
  11. Descendant · 3 generations on · 7 of its ownK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
Show all 9 generations
  1. Root · 9 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
  2. 8 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
  3. 7 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
  4. 6 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
  5. 5 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
  6. 4 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
  7. 3 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
  8. 2 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
  9. 1 generation backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
  10. This deviceK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2010: 12012: 52013: 22014: 32015: 52016: 12017: 42018: 52020: 12022: 12023: 12025: 2
2010high 5 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 31 · See all
  • K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · cites it directly30descendants
  • K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 2 generations on19descendants
  • K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on12descendants
  • K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · 3 generations on8descendants
  • K120426Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K913697Automatic Corneal ShaperHansa Research & Development, Inc.1991—
−8K972808Hansatome MicrokeratomeChiron Vision Corp.1997—
−7K993153Intralase 600C Laser KeratomeIntra Lase Corp.19991
−6K013941Pulsion FS Laser KeratomeIntra Lase Corp.20021
−5K031960Intralase FS LaserIntra Lase Corp.20033
−4K060372Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp.2006—
−3K063682Intralase Fusion LaserIntra Lase Corp.2007—
−2K073404Ifs Laser SystemIntra Lase Corp.2008—
−1K082947Lensx 550 Laser SystemLensx Lasers, Inc.2009—
0 (this device)K092647Lensx 550 Laser SystemLensx Lasers, Inc.2009—
+1K101626Lensx Laser SystemLensx Lasers, Inc.2010—
+2K113151Ifs Laser SystemAbbott Medical Optics, Inc.2012—
+2K120732Lenssx Laser SystemAlcon Lensx, Inc.20121
+3K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc.2014—
+3K120426Victus Laser PlatformTechnolas Perfect Vision GmbH2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198620
198710
198910
199010
199420
199510
199640
199760
199870
199910
200030
200130
200230
200430
200530

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201250
201320
201430
201550
201610
201740
201850
202010
202210
202310
202520
FIG. 1 — Lineage of K092647, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243896 LenSx Laser System (8065998162)score 16.8 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K082947Lensx 550 Laser System
Summary page 2
…510(K) SUMMARY 2.3 PREDICATE DEVICES 510(K) #TRADE NAME MANUFACTURER K082947 LenSx 550 Laser System LenSx Lasers, Inc. K04 1893 IntraLase ES Laser Abbott M…
Lensx Lasers, Inc.2009—
*K041893Intralase FS Laser
Summary page 2
…EVICES 510(K) #TRADE NAME MANUFACTURER K082947 LenSx 550 Laser System LenSx Lasers, Inc. K04 1893 IntraLase ES Laser Abbott Medical Optics K98 1063 Automated Corneal Trephine Laser…
Intra Lase Corp.2005—
*K981063Automated Corneal Trephine
Summary page 2
…TURER K082947 LenSx 550 Laser System LenSx Lasers, Inc. K04 1893 IntraLase ES Laser Abbott Medical Optics K98 1063 Automated Corneal Trephine Laser Center Development Cor…
Laser Center Dev. Corp.1998—
*K013151Asmotom Automated Trephine System
Summary page 2
…al Optics K98 1063 Automated Corneal Trephine Laser Center Development Corporation K013151 ASMOTOM Automated BKG Ophthalmics USA, Inc Trephine System K864520…
Bkg Opthalmics USA, Inc.2001—
*K864520Barron Rotary Blade Trephine Using Hessburg-Barron
Summary page 2
…Corporation K013151 ASMOTOM Automated BKG Ophthalmics USA, Inc Trephine System K864520 Barron Rotary Blade Trephine Precision Instruments, Inc. Using Hessburg-Barron K86 182…
Precision Instruments, Inc.1987—
*K861825Corneal Transplant Trephine Disposable Blade
Summary page 2
…Trephine System K864520 Barron Rotary Blade Trephine Precision Instruments, Inc. Using Hessburg-Barron K86 1825* Corneal Transplant Trephine Storz Instrument Co. ____________ Disposable Blade 2.4 DEVICE DESCRIPT…
Storz Instrument Co.1986—

Also cleared against K082947: 6 other devices →

What descends from it? (31)

See all 31

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101626Lensx Laser SystemLensx Lasers, Inc.201030

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 1.6 years on median.
  • 7 of the 50 ancestors have a recall of any class.
  • Of its descendants, K101626 (Lensx Lasers, Inc., 2010) has gone furthest, with 30 descendants of its own.
  • 6 other devices also cite its predicate K082947.

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

2009: 22010: 32011: 42012: 42013: 22014: 42015: 52016: 22017: 62018: 52020: 22021: 12022: 32023: 22025: 2
2007high 6 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OOE

129in 2022

2010: 131 days median2011: 132 days median2012: 138 days median2014: 133 days median2015: 151 days median2017: 81 days median2018: 99 days median2022: 129 days median
2007high 151 (2015) · low 81 (2017)2026

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

Recalls per year · OOE

1in 2021

2013: 12018: 12021: 1
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

2011: 102012: 742013: 1642014: 2642015: 6892016: 4822017: 4832018: 4342019: 3112020: 1992021: 3282022: 2042023: 2312024: 3252025: 438
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20092—00
2010313100
20114132010
20124138074
20132—1164
201441330264
201551510689
20162—0482
20176810483
20185991434
20190—0311
20202—0199
20211—1328
202231290204
20232—0231
20240—0325
20252—0438
20260—0—

What is it indicated for?

The LenSx 550 Laser System is indicated for use in the creation of a partial thickness cut/incision for lainellar keratoplasty and in the creation of a full-thickness cut/incision for penetrating keratoplasty.

Indications for use as stated in the FDA summary.

Also cleared against K082947

6 other devices cite the same predicate.

  • K110427Femtec Laser System for CapsulotomyTechnolas Perfect Vision GmbH · 2011
  • K112098TBDLensar, Inc. · 2011
  • K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 2011
  • K101626Lensx Laser SystemLensx Lasers, Inc. · 2010
  • K090633Lensar Laser SystemLensar, Inc. · 2010
  • K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010

More from Lensx Lasers, Inc.

4 FDA decisions under this applicant name. See the company

  • K101626Lensx Laser SystemLensx Lasers, Inc. · 2010
  • K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
  • K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009

Recent decisions in OOE

The OOE category page

  • K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc. · 2025
  • K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc. · 2025
  • K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc. · 2023
  • K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLC · 2023
  • K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc. · 2022

https://510kreport.com/device/K092647 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092647: Lensx 550 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092647

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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