510(k) · Cleared
Recalled · 2003Pulsion FS Laser Keratome
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 27, 2002 as substantially equivalent to K993153 (Intra Lase Corp., 1999) after a 90-day review. Its family tree reaches back 3 generations to 1991. 65 later devices descend from it. It has been recalled once.
- Decided
- Feb 27, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K913697 (1991). 4 ancestors in all, the oldest K892058 (1989). 65 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 2 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 1 generation backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- This deviceK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002
- Descendant · cites it directly · 61 of its ownK031960 Intralase FS LaserIntra Lase Corp. · 2003 · Recalled
- 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 · 52 of its ownK033354 Femtec Laser Microkeratome20/10 Perfect Vision Optische Gerate GmbH · 2004
Showing 5 of 65 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 65 · See all- K031960Intralase FS LaserIntra Lase Corp. · 2003 · cites it directly61descendants
- 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
- K033354Femtec Laser Microkeratome20/10 Perfect Vision Optische Gerate GmbH · 2004 · cites it directly52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −2 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −1 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| 0 (this device) | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | — |
| +1 | 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 | — |
| +2 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| +2 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
| +1 | K033354 | Femtec Laser Microkeratome | 20/10 Perfect Vision Optische Gerate GmbH | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 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 |
|---|---|---|---|
| * | K993153 | Intralase 600C Laser KeratomeSummary page 1…the predicate device or legally marketed device or devices to which substantial equivalence is being claimed: Company: Intralase Corp. Device: Pulsion FS Laser 510(k): K993153 Date Cleared: December 17, 1999 A description of the device that is the subject of the 510(k), including explanation of how the… | 1999 |
What descends from it? (65)
See all 657 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031960 | Intralase FS Laser | 2003 | 61 |
| K060372 | Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 | 2006 | 58 |
| K033354 | Femtec Laser Microkeratome | 2004 | 52 |
| K082947 | Lensx 550 Laser System | 2009 | 51 |
| K062314 | Horus Laser Keratome | 2006 | 15 |
| K100253 | Visumax Laser Keratome | 2010 | 14 |
| K053511 | DA Vinci Femtosecond Surgical Laser | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2003 | Not classified | Z-1124-03 | Other | Gantry moves toward patient when 'Home' button is used after procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K031960 (Intra Lase Corp., 2003) has gone furthest, with 61 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 Pulsion™ FS is an ophthalmic surgical laser indicated for use in the creation of a comneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
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/K013941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013941: Pulsion FS Laser Keratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013941
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026