510(k) · Cleared
ClearedWavelight FS200 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. Dba Alcon Laboratories, Inc. · OOE Ophthalmic Femtosecond Laser
Cleared on Sep 30, 2014 as substantially equivalent to K131207 (Surgical Instrument Engineering AG, 2013) and 3 other predicates after a 118-day review. Its family tree reaches back 12 generations to 1991. 8 later devices descend from it.
- Decided
- Sep 30, 2014
- Review
- 118 days
- Class
- Class II
- Product code
- OOE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K913697 (1991). 66 ancestors in all, the oldest K822112 (1982). 8 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 8 generations between
- 3 generations backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 2 generations backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- 1 generation backK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- This deviceK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK173346 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK181430 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK173660 LenSx Laser SystemAlcon Laboratories, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK243896 LenSx Laser System (8065998162)Alcon Laboratories, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK182795 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
Show all 12 generations
- Root · 12 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 11 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 10 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 9 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 8 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 7 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 6 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 5 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 4 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 3 generations backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 2 generations backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- 1 generation backK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- This deviceK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · cites it directly3descendants
- K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · 2 generations on2descendants
- K173660LenSx Laser SystemAlcon Laboratories, Inc. · 2018 · cites it directly2descendants
- K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc. · 2025 · 2 generations on1descendant
- K182795LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −11 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −10 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −9 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −8 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −7 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −6 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −5 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −4 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −3 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −2 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| −1 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| 0 (this device) | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| +1 | K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
| +2 | K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
| +1 | K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018 | — |
| +2 | K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025 | — |
| +1 | K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2010 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 5 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K131207 | Femto LDV (TM) Z-Generation Femtosecond Surgical LaserSummary page 5…aser 5.1 Predicate Devices: The legally marketed device(s) to which we are claiming substantial equivalence are: 510(k) Number Device K131207 FEMTO LDV Z6 K113151 iFS Laser System K101006 and WaveLight® FS200 Laser… | 2013 |
| * | K113151 | Ifs Laser SystemSummary page 5…he legally marketed device(s) to which we are claiming substantial equivalence are: 510(k) Number Device K131207 FEMTO LDV Z6 K113151 iFS Laser System K101006 and WaveLight® FS200 Laser System K121031 June 2014… | 2012 |
| * | K101006 | Wavelight FS200 Laser System Model: FS200Summary page 5…laiming substantial equivalence are: 510(k) Number Device K131207 FEMTO LDV Z6 K113151 iFS Laser System K101006 and WaveLight® FS200 Laser System K121031 June 2014… | 2010 |
| * | K121031 | Wavelight FS200 Patient Interface 1505Summary page 5…Device K131207 FEMTO LDV Z6 K113151 iFS Laser System K101006 and WaveLight® FS200 Laser System K121031 June 2014 Page 51 Traditional 510… | 2012 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 12 of the 66 ancestors have a recall of any class.
- Of its descendants, K173346 (Lensar, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K131207.
How does its category compare?
All OOE devicesOOE Ophthalmic Femtosecond Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OOE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OOE
129in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OOE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOE
438in 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 WaveLight FS200 Laser System is an ophthalmic surgical laser indicated for use: • In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. • In the creation of a lamellar cut/resection of the…
Read the full statement (121 words)
The WaveLight FS200 Laser System is an ophthalmic surgical laser indicated for use:
• In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
• In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
• In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.
• In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.
• In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea.
• In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/incisions in the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141476 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141476: Wavelight FS200 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/K141476
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