510(k) · Cleared
ClearedIfs Advanced Femtosecond Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amo Manufacturing USA, LLC · GEX Powered Laser Surgical Instrument
Cleared on Jan 6, 2015 as substantially equivalent to K131207 (Surgical Instrument Engineering AG, 2013) and 1 other predicate after a 181-day review. Its family tree reaches back 12 generations to 1991. 5 later devices descend from it.
- Decided
- Jan 6, 2015
- Review
- 181 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913697 (1991). 64 ancestors in all, the oldest K822112 (1982). 5 later devices descend from it, 3 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 deviceK141852 Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015
- 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 · 3 generations on · 0 of its ownK252682 LenSx Laser System (8065000944)Alcon Laboratories, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK223566 ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK173371 VisuMax Femtosecond LaserCarl Zeiss Meditec, 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 deviceK141852 Ifs Advanced Femtosecond Laser SystemAmo Manufacturing USA, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K173660LenSx Laser SystemAlcon Laboratories, Inc. · 2018 · cites it directly2descendants
- K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc. · 2025 · 2 generations on1descendant
- K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc. · 2025 · 3 generations on0descendants
- K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc. · 2023 · cites it directly0descendants
- K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc. · 2018 · cites it directly0descendants
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) | K141852 | Ifs Advanced Femtosecond Laser System | Amo Manufacturing USA, LLC | 2015 | — |
| +1 | K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018 | — |
| +2 | K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025 | — |
| +3 | K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | 2025 | — |
| +1 | K223566 | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | Johnson & Johnson Surgical Vision, Inc. | 2023 | — |
| +1 | K173371 | VisuMax Femtosecond Laser | Carl Zeiss Meditec, 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 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 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? (2)
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 4…marketed device or devices to which substantial equivalence is being claimed: 510(k) # Trade Name Manufacturer ____ K131207 FEMVTO LDV Z6 SIE AG, Femtosecond Surgical Laser Surgical Instrument Engineering… | 2013 |
| * | K113151 | Ifs Laser SystemSummary page 4…r ____ K131207 FEMVTO LDV Z6 SIE AG, Femtosecond Surgical Laser Surgical Instrument Engineering K113151 iFS Laser System AMO Manufacturing USA, LLC iFS Laser System AMO Manuf… | 2012 |
What descends from it? (5)
3 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 24 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 11 of the 64 ancestors have a recall of any class.
- Of its descendants, K173660 (Alcon Laboratories, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K131207.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
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 patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal In lamellar IEK and corneal harvesting In the creation of…
Read the full statement (127 words)
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 patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal
In lamellar IEK and corneal harvesting
In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
In the creation of a lamellar cut/resection of the cornea for lamellar IEK and for the creation of a penetrating cut/incision for penetrating IEK
In patients undergoing ophthalmic surgery or other treatment requiring the creation of corneal channel for placement/insertion of a corneal inlay device
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/K141852 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141852: Ifs Advanced Femtosecond 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/K141852
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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