510(k) · Cleared
Recalled · 2003Intralase 600C 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 Dec 17, 1999 as substantially equivalent to K972808 (Chiron Vision Corp., 1997) and 1 other predicate after an 87-day review. Its family tree reaches back 2 generations to 1991. 66 later devices descend from it. It has been recalled once.
- Decided
- Dec 17, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913697 (1991). 3 ancestors in all, the oldest K892058 (1989). 66 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 1 generation backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- This deviceK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999
- Descendant · cites it directly · 65 of its ownK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- Descendant · 2 generations on · 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
Showing 5 of 66 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 66 · See all- K013941Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · cites it directly65descendants
- K031960Intralase FS LaserIntra Lase Corp. · 2003 · 2 generations on61descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −1 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| 0 (this device) | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | — |
| +1 | 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 | — |
| +2 | K063682 | Intralase Fusion Laser | Intra Lase Corp. | 2007 | — |
| +2 | K073404 | Ifs Laser System | Intra Lase Corp. | 2008 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K972808 | Hansatome MicrokeratomeSummary page 1…device or legally marketed device or devices to which substantial equivalence is being claimed: Company: Bausch & Lomb Surgical Device: Hansatome Microkeratome 510(k): K972808 Date Cleared: October 31, 1997 Company: Intelligent Surgical Lasers Device: ISL QC2000 510(k): K892058 Date Cleared: June 15,… | 1997 |
| * | K892058 | ISL QC 2000Summary page 1…: Bausch & Lomb Surgical Device: Hansatome Microkeratome 510(k): K972808 Date Cleared: October 31, 1997 Company: Intelligent Surgical Lasers Device: ISL QC2000 510(k): K892058 Date Cleared: June 15, 1989 Intral.ase Corporation September 13, 1999 IntralLase 600C Laser Keratome Premarket N… | 1989 |
What descends from it? (66)
See all 665 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)
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 8 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K013941 (Intra Lase Corp., 2002) has gone furthest, with 65 descendants of its own.
- 6 other devices also cite its predicate K972808.
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 600C Laser Keratome is an ophthalmic surgical laser indicated for use in patients
undergoing 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/K993153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993153: Intralase 600C Laser Keratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993153
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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