510(k) · Cleared
ClearedFemtec Laser Microkeratome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
20/10 Perfect Vision Optische Gerate GmbH · GEX Powered Laser Surgical Instrument
Cleared on Feb 18, 2004 as substantially equivalent to K013941 (Intra Lase Corp., 2002) and 1 other predicate after a 121-day review. Its family tree reaches back 4 generations to 1991. 52 later devices descend from it.
- Decided
- Feb 18, 2004
- Review
- 121 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K913697 (1991). 6 ancestors in all, the oldest K892058 (1989). 52 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK913697 Automatic Corneal ShaperHansa Research & Development, Inc. · 1991
- 3 generations backK972808 Hansatome MicrokeratomeChiron Vision Corp. · 1997
- 2 generations backK993153 Intralase 600C Laser KeratomeIntra Lase Corp. · 1999 · Recalled
- 1 generation backK013941 Pulsion FS Laser KeratomeIntra Lase Corp. · 2002 · Recalled
- This deviceK033354 Femtec Laser Microkeratome20/10 Perfect Vision Optische Gerate GmbH · 2004
- 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
- Descendant · 3 generations on · 19 of its ownK113151 Ifs Laser SystemAbbott Medical Optics, Inc. · 2012
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- 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
- K113151Ifs Laser SystemAbbott Medical Optics, Inc. · 2012 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913697 | Automatic Corneal Shaper | Hansa Research & Development, Inc. | 1991 | — |
| −3 | K972808 | Hansatome Microkeratome | Chiron Vision Corp. | 1997 | — |
| −2 | K993153 | Intralase 600C Laser Keratome | Intra Lase Corp. | 1999 | 1 |
| −1 | K013941 | Pulsion FS Laser Keratome | Intra Lase Corp. | 2002 | 1 |
| 0 (this device) | K033354 | Femtec Laser Microkeratome | 20/10 Perfect Vision Optische Gerate GmbH | 2004 | — |
| +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 | — |
| +3 | K113151 | Ifs Laser System | Abbott Medical Optics, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 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 |
|---|---|---|---|
| * | K013941 | Pulsion FS Laser KeratomeSummary page 2…Page 45 of 46 Predicate Device Manufacturer 510(k) No. Date Cleared Pulsion FS Laser Intralase Corp. K013941 February 27, 2002 Keratome Hansatome Bausch & Lomb K010260 April 27, 20… | 2002 |
| * | K010260 | Hansatome MicrokeratomeSummary page 2…ed Pulsion FS Laser Intralase Corp. K013941 February 27, 2002 Keratome Hansatome Bausch & Lomb K010260 April 27, 2001 Microkeratome Surgical The materials, basic scientific concepts, and physica… | 2001 |
What descends from it? (52)
See all 523 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 13 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K082947 (Lensx Lasers, Inc., 2009) has gone furthest, with 51 descendants of its own.
- 6 other devices also cite its predicate K013941.
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 FemTecTM Laser Microkeratome is indicated for use in the creation of a corneal flap 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/K033354 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033354: Femtec Laser Microkeratome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033354
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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