510(k) · Cleared
ClearedWavelight FS200 Patient Interface 1505
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Research, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 21, 2012 as substantially equivalent to K101006 (Alcon Research, Ltd., 2010) after a 77-day review. Its family tree reaches back 9 generations to 1991. 10 later devices descend from it.
- Decided
- Jun 21, 2012
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K913697 (1991). 31 ancestors in all, the oldest K860001 (1986). 10 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 5 generations between
- 3 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 2 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 1 generation backK101006 Wavelight FS200 Laser System Model: FS200Alcon Research, Ltd. · 2010 · Recalled
- This deviceK121031 Wavelight FS200 Patient Interface 1505Alcon Research, Ltd. · 2012
- Descendant · cites it directly · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK173346 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK181430 LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK173660 LenSx Laser SystemAlcon Laboratories, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK243896 LenSx Laser System (8065998162)Alcon Laboratories, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 8 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 7 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 6 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 5 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 4 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 3 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 2 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 1 generation backK101006 Wavelight FS200 Laser System Model: FS200Alcon Research, Ltd. · 2010 · Recalled
- This deviceK121031 Wavelight FS200 Patient Interface 1505Alcon Research, Ltd. · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · cites it directly8descendants
- K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · 2 generations on3descendants
- K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018 · 3 generations on2descendants
- K173660LenSx Laser SystemAlcon Laboratories, Inc. · 2018 · 2 generations on2descendants
- K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −8 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −7 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −6 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −5 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −4 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −3 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −2 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −1 | K101006 | Wavelight FS200 Laser System Model: FS200 | Alcon Research, Ltd. | 2010 | 1 |
| 0 (this device) | K121031 | Wavelight FS200 Patient Interface 1505 | Alcon Research, Ltd. | 2012 | — |
| +1 | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| +2 | K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
| +3 | K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018 | — |
| +2 | K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018 | — |
| +3 | K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025 | — |
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 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K101006 | Wavelight FS200 Laser System Model: FS200Summary page 1…rgical Instrument (per 21 CFR 878.4810) 5.1 Predicate Device The legally marketed device to which we are claiming equivalence to is: 510(k) Number Device K101006 WaveLight®FS200 Patient Interface 1504 (Consumable cleared with the WaveLight® FS200 Lase… | 2010 |
What descends from it? (10)
2 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 21 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 7 of the 31 ancestors have a recall of any class.
- Of its descendants, K141476 (Alcon Research, Ltd. Dba Alcon Laboratories, Inc., 2014) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K101006.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The WaveLight® FS200 Patient Interface 1505 is indicated to be used with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121031: Wavelight FS200 Patient Interface 1505.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121031
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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