510(k) · Cleared
ClearedIntralase FS Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intra Lase Corp. · GEX Powered Laser Surgical Instrument
Cleared on Jul 29, 2005 as substantially equivalent to K981063 (Laser Center Dev. Corp., 1998) and 2 other predicates after a 381-day review. Its family tree reaches back 3 generations to 1995. 60 later devices descend from it.
- Decided
- Jul 29, 2005
- Review
- 381 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K954058 (1995). 6 ancestors in all, the oldest K864520 (1987). 60 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK954058 Barraquer-Krumeich Refractive SetEyetech M.V.A. · 1995
- 2 generations backK980675 Summit Krumeich-Barraquer MicrokeratomeSummit Technology, Inc. · 1998 · Recalled
- 1 generation backK013151 Asmotom Automated Trephine SystemBkg Opthalmics USA, Inc. · 2001
- This deviceK041893 Intralase FS LaserIntra Lase Corp. · 2005
- Descendant · cites it directly · 58 of its ownK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- Descendant · 2 generations on · 57 of its ownK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- Descendant · 2 generations on · 56 of its ownK073404 Ifs Laser SystemIntra Lase Corp. · 2008
- Descendant · cites it directly · 51 of its ownK082947 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
- Descendant · 2 generations on · 47 of its ownK094052 Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K060372Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006 · cites it directly58descendants
- K063682Intralase Fusion LaserIntra Lase Corp. · 2007 · 2 generations on57descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · 2 generations on56descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · cites it directly51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954058 | Barraquer-Krumeich Refractive Set | Eyetech M.V.A. | 1995 | — |
| −2 | K980675 | Summit Krumeich-Barraquer Microkeratome | Summit Technology, Inc. | 1998 | 1 |
| −1 | K013151 | Asmotom Automated Trephine System | Bkg Opthalmics USA, Inc. | 2001 | — |
| 0 (this device) | K041893 | Intralase FS Laser | Intra Lase Corp. | 2005 | — |
| +1 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| +2 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| +2 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| +1 | K082947 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
| +2 | K094052 | Lensx 550 Laser System. Model 550 | Lensx Lasers, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 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 |
|---|---|---|---|
| * | K981063 | Automated Corneal TrephineSummary page 1…FICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED: - 510(k) Applicant Name of Device Date Cleared K981063 Laser Center Automated Corneal June 23, 1998 Development Trephine Corporation K013151 BKG Ophthalmics ASMOTOM Automated | Decembe… | 1998 |
| * | K013151 | Asmotom Automated Trephine SystemSummary page 1…NTIAL EQUIVALENCE IS BEING CLAIMED: - 510(k) Applicant Name of Device Date Cleared K981063 Laser Center Automated Corneal June 23, 1998 Development Trephine Corporation K013151 BKG Ophthalmics ASMOTOM Automated | December 14, USA, Inc. Corneal Trephine 2001 K002890 | IntraLase Corporation Femtosecond Lase… | 2001 |
| * | K002890 | Intralase 600C Laser KeratomeSummary page 1…63 Laser Center Automated Corneal June 23, 1998 Development Trephine Corporation K013151 BKG Ophthalmics ASMOTOM Automated | December 14, USA, Inc. Corneal Trephine 2001 K002890 | IntraLase Corporation Femtosecond Laser August 9, 2001 Keratome K041893 - IntraLase FS Laser Response to Deficiencies Page 17… | 2001 |
What descends from it? (60)
See all 607 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | 2006 | 58 |
| K082947 | Lensx 550 Laser System | 2009 | 51 |
| K092647 | Lensx 550 Laser System | 2009 | 31 |
| K101626 | Lensx Laser System | 2010 | 30 |
| K100253 | Visumax Laser Keratome | 2010 | 14 |
| K120732 | Lenssx Laser System | 2012 | 12 |
| K082043 | Carriazo-Pendular Microkeratome | 2008 | 0 |
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 10 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K060372 (Intra Lase Corp., 2006) has gone furthest, with 58 descendants of its own.
- 1 other device also cites its predicate K981063.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 INTRALASE® FS Laser is an ophthalmic surgical laser with the following indications for use: In patients undergoing surgery or other treatment requiring intial 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 the corneal ring segments In lamellar keratoplasty and corneal harvesting In the creation of a corneal flap in patients…
Read the full statement (105 words)
The INTRALASE® FS Laser is an ophthalmic surgical laser with the following indications for use:
In patients undergoing surgery or other treatment requiring intial 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 the corneal ring segments
In lamellar keratoplasty 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 keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
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/K041893 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041893: Intralase FS Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041893
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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