510(k) · Cleared
ClearedIntralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3
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 Aug 16, 2006 as substantially equivalent to K993153 (Intra Lase Corp., 1999) and 5 other predicates after a 184-day review. Its family tree reaches back 5 generations to 1991. 58 later devices descend from it.
- Decided
- Aug 16, 2006
- Review
- 184 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K913697 (1991). 14 ancestors in all, the oldest K864520 (1987). 58 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 4 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 3 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 2 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 1 generation backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- This deviceK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- Descendant · cites it directly · 57 of its ownK063682 Intralase Fusion LaserIntra Lase Corp. · 2007
- Descendant · cites it directly · 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
- Descendant · 2 generations on · 31 of its ownK092647 Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K063682Intralase Fusion LaserIntra Lase Corp. · 2007 · cites it directly57descendants
- K073404Ifs Laser SystemIntra Lase Corp. · 2008 · cites it directly56descendants
- K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · cites it directly51descendants
- K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010 · 2 generations on47descendants
- K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −4 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −3 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −2 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −1 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| 0 (this device) | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| +1 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| +1 | 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 | — |
| +2 | K092647 | Lensx 550 Laser System | Lensx Lasers, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K993153 | Intralase 600C Laser KeratomeSummary page 2…ary 5.3 IDENTIFICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED: 510(k) # Trade Name Manufacturer K993153 IntraLase 600C Laser Keratome IntraLase Corp. K001211 intraLase 600C Laser Keratome IntraLase Corp. K002890 IntraLase 600C Laser… | 1999 |
| * | K001211 | Modification to Intralase 600C Laser KeratomeSummary page 2…LLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED: 510(k) # Trade Name Manufacturer K993153 IntraLase 600C Laser Keratome IntraLase Corp. K001211 intraLase 600C Laser Keratome IntraLase Corp. K002890 IntraLase 600C Laser Keratome IntraLase Corp. K013941 Pulsion FS Laser Kera… | 2000 |
| * | K002890 | Intralase 600C Laser KeratomeSummary page 2…UIVALENCE IS BEING CLAIMED: 510(k) # Trade Name Manufacturer K993153 IntraLase 600C Laser Keratome IntraLase Corp. K001211 intraLase 600C Laser Keratome IntraLase Corp. K002890 IntraLase 600C Laser Keratome IntraLase Corp. K013941 Pulsion FS Laser Keratome IntraLase Corp. K031960 IntraLase FS Laser IntraL… | 2001 |
| * | K013941 | Pulsion FS Laser KeratomeSummary page 2…cturer K993153 IntraLase 600C Laser Keratome IntraLase Corp. K001211 intraLase 600C Laser Keratome IntraLase Corp. K002890 IntraLase 600C Laser Keratome IntraLase Corp. K013941 Pulsion FS Laser Keratome IntraLase Corp. K031960 IntraLase FS Laser IntraLase Corp. K041893 IntraLase FS Laser IntraLase Corp.… | 2002 |
| * | K031960 | Intralase FS LaserSummary page 2…aLase Corp. K001211 intraLase 600C Laser Keratome IntraLase Corp. K002890 IntraLase 600C Laser Keratome IntraLase Corp. K013941 Pulsion FS Laser Keratome IntraLase Corp. K031960 IntraLase FS Laser IntraLase Corp. K041893 IntraLase FS Laser IntraLase Corp. 5.4 A DESCRIPTION OF THE DEVICE THAT IS THE SUBJEC… | 2003 |
| * | K041893 | Intralase FS LaserSummary page 2…ratome IntraLase Corp. K002890 IntraLase 600C Laser Keratome IntraLase Corp. K013941 Pulsion FS Laser Keratome IntraLase Corp. K031960 IntraLase FS Laser IntraLase Corp. K041893 IntraLase FS Laser IntraLase Corp. 5.4 A DESCRIPTION OF THE DEVICE THAT IS THE SUBJECT OF THE 510(K), INCLUDING EXPLANATION OF H… | 2005 |
What descends from it? (58)
See all 586 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 15 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K063682 (Intra Lase Corp., 2007) has gone furthest, with 57 descendants of its own.
- 4 other devices also cite its predicate K993153.
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 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 corneal flap in patients…
Read the full statement (104 words)
The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use:
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 corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the comea;
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/K060372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060372
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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