510(k) · Cleared
ClearedIntralase Fusion 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 Feb 9, 2007 as substantially equivalent to K060372 (Intra Lase Corp., 2006) after a 60-day review. Its family tree reaches back 6 generations to 1991. 57 later devices descend from it.
- Decided
- Feb 9, 2007
- Review
- 60 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913697 (1991). 15 ancestors in all, the oldest K864520 (1987). 57 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 5 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 4 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 3 generations backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- 2 generations backK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 1 generation backK060372 Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3Intra Lase Corp. · 2006
- This deviceK063682 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
- Descendant · 2 generations on · 30 of its ownK101626 Lensx Laser SystemLensx Lasers, Inc. · 2010
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- 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
- K101626Lensx Laser SystemLensx Lasers, Inc. · 2010 · 2 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −5 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −4 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −3 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| −2 | K031960 | Intralase FS Laser | Intra Lase Corp. | 2003 | 3 |
| −1 | K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | Intra Lase Corp. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K101626 | Lensx Laser System | Lensx Lasers, Inc. | 2010 | — |
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 |
|---|---|---|
| 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? (1)
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…CE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED: 510(k) # Trade Name Manufacturer K060372 IntraLase FS Laser IntraLase Corp. A DESCRIPTION OF THE DEVICE THAT IS THE SUBJECT OF THE 510(K), INCL… | 2006 |
What descends from it? (57)
See all 573 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 16 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 6 of the 15 ancestors have a recall of any class.
- Of its descendants, K073404 (Intra Lase Corp., 2008) has gone furthest, with 56 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. 2007, 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 IntraLase FusionJ Laser is an ophthalmic surgical laser indicated for use in the creation of
corneal flaps in patients undergoing LASIK surgery or other treatment requiring initial lamellar
resection of the cornea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063682 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063682: Intralase Fusion Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063682
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