510(k) · Cleared
ClearedIfs Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical Optics, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 8, 2012 as substantially equivalent to K101626 (Lensx Lasers, Inc., 2010) and 2 other predicates after a 135-day review. Its family tree reaches back 11 generations to 1991. 19 later devices descend from it.
- Decided
- Mar 8, 2012
- Review
- 135 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K913697 (1991). 61 ancestors in all, the oldest K822112 (1982). 19 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 7 generations between
- 3 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 2 generations backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 1 generation backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- This deviceK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
- Descendant · cites it directly · 8 of its ownK141476 Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014
- Descendant · cites it directly · 7 of its ownK120426 Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012
- Descendant · cites it directly · 6 of its ownK122386 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013
- Descendant · cites it directly · 5 of its ownK141852 Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015
- Descendant · 2 generations on · 5 of its ownK132534 Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014
Show all 11 generations
- Root · 11 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 10 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 9 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 8 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 7 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 6 generations backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- 5 generations backK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- 4 generations backK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- 3 generations backK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 2 generations backK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- 1 generation backK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
- This deviceK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K141476Wavelight FS200 Laser SystemAlcon Research, Ltd. Dba Alcon Laboratories, Inc. · 2014 · cites it directly8descendants
- K120426Victus Laser PlatformTechnolas Perfect Vision GmbH · 2012 · cites it directly7descendants
- K122386Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2013 · cites it directly6descendants
- K141852Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015 · cites it directly5descendants
- K132534Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −10 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −9 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −8 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −7 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −6 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| −5 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| −4 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| −3 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −2 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| −1 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
| 0 (this device) | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
| +1 | K141476 | Wavelight FS200 Laser System | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014 | — |
| +1 | K120426 | Victus Laser Platform | Technolas Perfect Vision GmbH | 2012 | — |
| +1 | K122386 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2013 | — |
| +1 | K141852 | Ifs Advanced Femtosecond Laser System | Amo Manufacturing USA, LLC | 2015 | — |
| +2 | K132534 | Victus Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2014 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K101626 | Lensx Laser SystemSummary page 1…E OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED: 510(k) # Trade Name Manufacturer K101626 LenSx 550 Laser System LenSx Lasers K073404 IntraL-ase ES Laser IntraL-as… | 2010 |
| * | K073404 | Ifs Laser SystemSummary page 1…IS BEING CLAIMED: 510(k) # Trade Name Manufacturer K101626 LenSx 550 Laser System LenSx Lasers K073404 IntraL-ase ES Laser IntraL-ase Corp. K863725 Cataract Diamond Knife Medic… | 2008 |
| * | K863725 | Cataract Diamond KnifeSummary page 1…Manufacturer K101626 LenSx 550 Laser System LenSx Lasers K073404 IntraL-ase ES Laser IntraL-ase Corp. K863725 Cataract Diamond Knife Medical Technology Dev… | 1986 |
What descends from it? (19)
See all 194 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 5 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 61 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.
- 6 other devices also cite its predicate K101626.
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 IFS Laser System is an ophthalmic surgical laser indicated for use: * In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea * In patients undergoing surgery or other 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…
Read the full statement (124 words)
The IFS Laser System is an ophthalmic surgical laser indicated for use:
* In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
* In patients undergoing surgery or other 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 lamellar keratoplasty and corneal harvesting
* In the creation of a lamellar cuttresection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
* In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113151: Ifs 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/K113151
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