510(k) · Cleared
ClearedWaveLight FS200 Patient Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alcon Laboratories, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 26, 2019 as substantially equivalent to K121031 (Alcon Research, Ltd., 2012) after a 35-day review. Its family tree reaches back 10 generations to 1991.
- Decided
- Mar 26, 2019
- Review
- 35 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K913697 (1991). 32 ancestors in all, the oldest K860001 (1986). No later device cites it as a predicate yet.
- Root · 10 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 6 generations between
- 3 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 2 generations backK101006 Wavelight FS200 Laser System Model: FS200Alcon Research, Ltd. · 2010 · Recalled
- 1 generation backK121031 Wavelight FS200 Patient Interface 1505Alcon Research, Ltd. · 2012
- This deviceK190392 WaveLight FS200 Patient InterfaceAlcon Laboratories, Inc. · 2019
Show all 10 generations
- Root · 10 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 9 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 8 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 7 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 6 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 5 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 4 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 3 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 2 generations backK101006 Wavelight FS200 Laser System Model: FS200Alcon Research, Ltd. · 2010 · Recalled
- 1 generation backK121031 Wavelight FS200 Patient Interface 1505Alcon Research, Ltd. · 2012
- This deviceK190392 WaveLight FS200 Patient InterfaceAlcon Laboratories, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −9 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −8 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −7 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −6 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −5 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −4 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −3 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −2 | K101006 | Wavelight FS200 Laser System Model: FS200 | Alcon Research, Ltd. | 2010 | 1 |
| −1 | K121031 | Wavelight FS200 Patient Interface 1505 | Alcon Research, Ltd. | 2012 | — |
| 0 (this device) | K190392 | WaveLight FS200 Patient Interface | Alcon Laboratories, Inc. | 2019 | — |
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 |
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 |
|---|---|---|---|
| * | K121031 | Wavelight FS200 Patient Interface 1505Summary page 4…Ophthalmic Product Code: GEX/HNO Predicate Device: Trade/Proprietary Name: WaveLight® FS200 Patient Interface 1505 510(k) Number: K121031 FDA Clearance Date: June 21, 2012 Submitter: Alcon Research, Ltd. 6201… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 32 ancestors have a recall of any class.
- 1 other device also cites its predicate K121031.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 1515 is indicated to be used only with the WaveLight FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.
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/K190392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190392: WaveLight FS200 Patient Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190392
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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