510(k) · Cleared
Recalled · 2011Wavelight FS200 Laser System Model: FS200
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 Oct 21, 2010 as substantially equivalent to K060372 (Intra Lase Corp., 2006) and 2 other predicates after a 192-day review. Its family tree reaches back 8 generations to 1991. 21 later devices descend from it. It has been recalled once.
- Decided
- Oct 21, 2010
- Review
- 192 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K913697 (1991). 30 ancestors in all, the oldest K860001 (1986). 21 later devices descend from it, 3 citing it directly.
- 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 deviceK101006 Wavelight FS200 Laser System Model: FS200Alcon Research, Ltd. · 2010
- Descendant · cites it directly · 12 of its ownK120732 Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · Recalled
- Descendant · cites it directly · 10 of its ownK121031 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 · 5 of its ownK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
- Descendant · 2 generations on · 5 of its ownK123120 Lensx Laser SystemAlcon Lensx, Inc. · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K120732Lenssx Laser SystemAlcon Lensx, Inc. · 2012 · cites it directly12descendants
- K121031Wavelight FS200 Patient Interface 1505Alcon Research, Ltd. · 2012 · cites it directly10descendants
- K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · cites it directly8descendants
- K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · 2 generations on5descendants
- K123120Lensx Laser SystemAlcon Lensx, Inc. · 2012 · 2 generations on5descendants
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) | K101006 | Wavelight FS200 Laser System Model: FS200 | Alcon Research, Ltd. | 2010 | — |
| +1 | K120732 | Lenssx Laser System | Alcon Lensx, Inc. | 2012 | 1 |
| +1 | 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 | K132534 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
| +2 | K123120 | Lensx Laser System | Alcon Lensx, Inc. | 2012 | — |
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 |
|---|---|---|
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Summary page 1…Laser Surgical Instrument 1. Predicate Devices: The legally marketed device(s) to which we are claiming substantial equivalence are: 510(k) Number Device K060372 FS Laser System K032910 Carriazo Pendular Keratome K073404 iFS Laser System… | 2006 |
| * | K032910 | Carriazo PendularSummary page 1…Devices: The legally marketed device(s) to which we are claiming substantial equivalence are: 510(k) Number Device K060372 FS Laser System K032910 Carriazo Pendular Keratome K073404 iFS Laser System 2. Device Description: The WaveLight® FS2… | 2004 |
| * | K073404 | Ifs Laser SystemSummary page 1…are claiming substantial equivalence are: 510(k) Number Device K060372 FS Laser System K032910 Carriazo Pendular Keratome K073404 iFS Laser System 2. Device Description: The WaveLight® FS200 Laser System is a stationary scanning-spot ferrto… | 2008 |
What descends from it? (21)
See all 213 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 18, 2011 | Not classified | Z-2292-2011 | Other | The software calculating the patterns were found to has a rounding error for certain parameter ranges. These rounding errors could result in an incomplete cut in the donor or patient tissue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 30 ancestors have a recall of any class.
- Of its descendants, K120732 (Alcon Lensx, Inc., 2012) has gone furthest, with 12 descendants of its own.
- 5 other devices also cite its predicate K060372.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 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 lamnellar cut/resection of the cornea for lamellar keratoplasty.
In the creation of a penetrating cut/incision for penetrating keratoplasty and for comneal harvesting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101006 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101006: Wavelight FS200 Laser System Model: FS200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101006
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